Regulatory Information
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Stakeholders Comments Organized by FDAMA Objectives
FDAMA Objective: A
Maximizing the availability and clarity of information about the process for review of applications and submissions (including petitions, notifications and any other similar forms of request) made under this Act.
| 11023 | Streamline the process for approval of food and color additive petitions |
| 11063 | Develop a simplified Generally Recognized as Safe (GRAS) notification procedure, in addition to the current procedure |
| 11067 | Significantly improve the food additive approval process to increase efficiency, predictability, and accountability |
| 11068 | Enhance communication in the food additive approval process with emphasis on presubmission consultations |
| 11103 | Place notifications for health claims in a public docket so that interested parties can review the submission and provide comments to the Agency on the scientific validity of the claim |
| 12021 | Improve information provided to consumers and improve clinical trial information provided to regulatory and health care professionals |
| 12057 | Collaborate and interact more with the regulated industries to avoid issuing guidance documents that do not adequately take into account useful perspectives that can be provided by industry to the Food and Drug Administration (FDA) |
| 12058 | Model Agency and industry interaction after that used for pregnancy labeling; by contrast, the guidance on gender was unproductive because it was issued as a final rule without industry input |
| 12068 | Make sure true experts of the disease under review are represented on the Advisory Panel, given the deference that FDA gives these panels |
| 12069 | Utilize expertise from the World Federation of Neurology and the Committee of Motor Neuron Disease in the Amyotrophic Lateral Sclerosis (ALS) review process |
| 12070 | Use ad hoc review from experts in diseases such as ALS |
| 12071 | Explore further options to effectively incorporate patient testimonies into the process |
| 12072 | Educate patient advocacy groups, disease-specific organizations, disease experts, and new biotechnology companies about FDA's function, process, and scope |
| 12073 | Solicit information regarding potentially effective drugs in certain diseases from the disease-specific groups |
| 12084 | Arrange public input in Advisory Panels so that data remains scientific rather than emotional |
| 12089 | Collaborate with the Pharmaceutical Research and Manufacturers of America (PhRMA) in the development of guidance documents and pilot programs instead of soliciting PhRMA's input after guidance issued or pilot programs are initiated |
| 12103 | Have Congress investigate the publishing processes for information about results of clinical trials and provide the FDA with adequate resources to monitor clinical trial quality |
| 12113 | Time public comment periods in Advisory Committee meetings after the sponsor and the Agency have both had a chance to present data and discuss it |
| 12151 | Develop methods for candidly presenting approval issues to the public |
| 12171 | Ensure that Advisory Committee members have the adequate skill level necessary |
| 12172 | Include at least one clinical pharmacologist and one biopharmaceutical scientist on every Advisory Committee |
| 12175 | Dedicate resources and staff to ensure that public reporting of all clinical trials is done as required under the Food and Drug Administration Modernization Act (FDAMA) |
| 13005 | Convene a working group from the regulated industries to review present Agency use of Advisory Panels and make recommendations as to how the process might be improved to maximize their utility to the FDA |
| 13007 | Reach out to stakeholders for discussion of outdated or vague regulations or guidance documents |
| 13012 | Make procedures more transparent, particularly in terms of Good Review Practices (GRPs) |
| 13013 | Provide to industry and stakeholders copies of GRPs, as well as Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) Reviewer Handbooks, plus Manual of Policies and Procedures (MaPPS) for New Drug Application (NDA) and Investigational New Drug (IND) reviews, even though these documents may still be in draft form |
| 13014 | Allow more time for companies to respond to FDA proposed labeling changes near the end of the review period |
| 13015 | FDA should put information about all new products on the Internet at the time of approval |
| 13038 | Take further steps in publishing proposed regulations in a timely fashion, providing adequate comment periods, providing early dissemination of draft guidance documents, and holding more frequent Agency workshops on regulatory changes |
| 13039 | Strictly adhere to the FDA Good Guidance Practices document |
| 13040 | Broaden the Good Guidance Practices document's scope of application |
| 13041 | Work with groups like the Coalition for Regulatory Reform (CFRR) and others in developing even initial drafts of Agency guidance documents |
| 13045 | Issue guidance documents specific to blood and plasma for CBE30 Supplements (changes to an approved application) |
| 13046 | Issue guidance documents specific to blood and plasma for annual reports |
| 13047 | Issue guidance specific to blood and plasma for comparability protocols |
| 13048 | Engage industry in a dialogue about the pilot program for approval of certain blood and plasma products through a monograph system |
| 13064 | Expand the use of guidance documents and notifications to facilitate licensed blood center use of new technologies where the technology has a proven track record for many years, or where the benefits clearly outweigh the risks |
| 13077 | Develop clear guidelines for the use of the comparability protocol process |
| 13079 | Think more innovatively about improving the ranking and grading of specific blood and blood products as the foundation of the blood licensure review process |
| 13083 | Define what information is necessary to evaluate the licensure submission reviews |
| 13084 | Create a tier for submissions and reviews based on hazard and impact |
| 13089 | Guidance should describe the obligations of both the sponsor and the FDA in setting up meetings |
| 13090 | Have a classification for meetings (e.g., A, B, C) with defined timelines (e.g., 30, 60, 75 days) for holding the meeting after the request |
| 13091 | Prepare common minutes from meetings to be provided by FDA within 30 days with comments from the sponsor within 10 days |
| 13092 | Have monthly updates or a progress report of a submission, specifically a fast track submission |
| 13094 | Define the concept of a comparability protocol |
| 13102 | Include discussion of the selection process for surrogate end points in guidance documents |
| 13105 | Provide recommendations in the surrogate end point guidance document with regard to quality-of life-scales as perhaps the primary clinical end point |
| 13106 | Provide recommendations and guidance in the surrogate end point guidance document with regard to dissemination of information on surrogate end points |
| 13110 | Notify the sponsor in advance of the withdrawal of a fast track designation and give them an opportunity to meet informally with the FDA prior to the final notification |
| 13113 | Develop a general schedule with the sponsor, with major action dates and milestones, so that both parties are very clear on what is expected when an IND receives a fast track designation |
| 13114 | Work with sponsors to obtain early approval and agreement on the protocol for a fast track IND |
| 13115 | Create an information or tracking system for fast track New Drug Applications/Biologic License Applications (NDA/BLAs) that allows companies to track the status of their NDA/BLA through the process |
| 13137 | Adopt CBER's model of providing the sponsor a copy of the draft submission document prior to submitting it to the Advisory Panel |
| 13138 | Put more self-reviewing or self-policing mechanisms in place (e.g., defining and developing more uniform timetables Agency-wide that would be adhered to) |
| 13153 | Configure Advisory Committees to have consumer representatives as an essential component in the FDA regulatory process |
| 13154 | Continue to use consumer advisors |
| 13164 | Communicate via a policy memorandum any decisions that come out of back and forth communication with industry, building upon guidance documents that exist |
| 13165 | Provide as much feedback to industry as possible in the earliest time frame because many of the questions that are generated will result in long-term experiments or clinical trials |
| 14001 | Formally communicate the basis for significant new submission/review requirements to industry before demanding compliance |
| 14045 | Make the Center for Veterinary Medicine's (CVM's) stakeholder involvement in decision-making a transparent process but formalized through the Federal Register; a good model to follow is the United States Department of Agriculture's (USDA's) building the Hazard Analysis Critical Control Points (HACCP) rule |
| 14052 | Do a better job of developing and explaining to stakeholders the principles that guided policy decisions (i.e., the evaluation of needs of the animal versus needs of the public) |
| 14076 | Work closely with sponsors to ensure submissions are in the proper format, possibly through the use of a sample submission guide |
| 14078 | Target key industry persons who can provide alerts on new products that are in the pipeline to the Federal Register and have already been approved by the FDA |
| 14095 | Continue emphasis on providing education, information, and compliance assistance to regulated industry |
| 14096 | Use teleconferencing and the Internet to communicate with the industry |
| 14097 | Partner with industry organizations to produce brief, concise, and consumable information that will be useful for smaller establishments |
| 14104 | Use industry organizations to assist in developing literature that uses industry terminology, writing in a less regulatory way, and stressing the importance of compliance |
| 14113 | Make science-based decision-making understandable and clear |
| 14116 | Include a broad variety of scientists, such as chemists, physiologists, immunologists, biostatisticians, etc., in the CVM Advisory Committee, not just clinicians |
| 15018 | Publish a flow chart of all the internal processes that FDA has for all submissions, e.g., 510 (k)s, Device Premarket Approval Applications (PMAs), Investigational Device Exemptions (IDEs), etc. to promote better understanding |
| 15019 | Make available more templates, prototypes, and examples to give industry greater understanding |
| 15033 | Put prototype abbreviated submissions on the web and give clear instructions and encouragement on how to use them |
| 15039 | Revisit the structure and number of FDA Advisory Committees in order to increase the number of participants, broaden the committee's mission, and increase the total number of committees |
| 15047 | Clarify FDA expectations better to industry to help minimize differences of scientific opinion, and so the industry knows exactly what is needed from them to move forward efficiently |
| 15058 | Make consumer representatives on Advisory Panels an integral part of the process from the beginning |
| 15062 | Prepare the consumer representatives on Advisory Panels for their role and be invested in helping them overcome the technical and cultural barriers. |
FDAMA Objective: B
Maximizing the availability and clarity of information for consumers and patients concerning new products.
| 11030 | Increase the amount and effectiveness of food safety educational efforts for food preparers and food service at the retail level and the home |
| 11038 | Develop educational programs for consumers, with a special emphasis on children, young adults, and other vulnerable populations |
| 11076 | Increase the number of educational programs for consumers and food handlers |
| 11101 | Target programs that ensure that consumers know what they are buying and act decisively in cases of mislabeled products |
| 11105 | Develop effective communication strategies about dietary supplements for use by health professionals by working with the American Dietetics Association (ADA), the American Heart Association (AHA), and the National Institutes of Health's (NIH's) Office of Dietary Supplements, among others |
| 11106 | Research consumer perception of labeling information of foods and dietary supplements, sharing the cost among the FDA, the food and dietary supplement industry, and other organizations |
| 12001 | Make FDA an information source |
| 12004 | Reevaluate CDER's policy on direct-to-consumer advertising |
| 12005 | Submit a formal CDER proposal to the administration for delivery to Congress to permit distribution of peer-reviewed articles on unapproved uses directly to prescribers |
| 12006 | Stay the course with FDA's policy on controlling marketing through pharmacy benefits management companies (PBMs) directly to physicians and pharmacists |
| 12009 | Use a consumer panel to assess reactions to drug advertisements |
| 12010 | Do not depend on scientists to review direct-to-consumer advertisements |
| 12011 | Define appropriate direct-to-consumer messages; they may be different for individual drugs |
| 12012 | Solicit input and directions from health care professionals and ethnic communities in the review processes for direct-to-consumer advertisements |
| 12021 | Improve information provided to consumers as well as clinical trial information provided to regulatory and health care professionals |
| 12022 | Ensure the validity of and integrity of drug information provided on the Internet |
| 12023 | Improve information dissemination by using articles in professional journals, Internet messages, consumer articles, and news media |
| 12024 | Counter some of the direct-to-consumer advertisements by using radio and television ads, consumer magazines, and health or trade magazines |
| 12025 | Place drug information in physicians' offices, patients' rooms in hospitals, and in emergency rooms for consumers' access |
| 12026 | Improve access to package inserts for both the public and regulators |
| 12027 | Use an FDA Internet board to provide drug information to various entities |
| 12045 | Continue FDA's policy on direct-to-consumer ads that serve the public health interest, particularly with the increased move to self-care management |
| 12049 | Give health care providers needed access to the latest scientific information on medicines |
| 12050 | Distinguish dissemination of information from promotion |
| 12051 | Consider that information on off-label use, such as peer-reviewed scientific journal articles, is appropriate to provide to health-care providers by research pharmaceutical manufacturers |
| 12052 | Assure that any regulatory limitations on the flow of off-label use information is: a) minimally intrusive, and b) consistent with constitutionally guaranteed speech rights and FDAMA |
| 12053 | Consider electronic package inserts as a positive means of spreading information to consumers and health care professionals |
| 12055 | Collaborate with the pharmaceutical industry to educate Congress, the press, and the public about the vast amount of safety activities already in place |
| 12082 | Begin to organize information on how FDA counsels people, collects data on them, and makes sure that consumers know how to use products |
| 12106 | Rethink FDA's role regarding direct-to-consumer advertising |
| 12107 | Find ways to strengthen standards for direct-to-consumer advertising |
| 12108 | Request more resources for more aggressive policing of ad content |
| 12109 | Include a greater emphasis on public education as part of monitoring direct-to-consumer advertising |
| 12110 | Make the public aware when companies have been asked to revise or pull ads, and explain why |
| 12112 | Ensure that consumers have access to an independent source of information on drugs that can match the accessibility of savvy direct-to-consumer advertising |
| 12114 | Commission research to determine which formats of supplemental written information are most useful in terms of improving consumers' medicine adherence and health outcomes as determined by a health care professional |
| 12115 | Commission research to determine which formats of supplemental written information are most useful in terms of improving information exchange between the patient health care professionals |
| 12116 | Support the development of a collaborative, national consumer medicine safety and education program to educate consumers and health providers about changes and improvements in prescription medicine information |
| 12117 | Support the development of a collaborative, national consumer medicine safety and education program to promote question asking and information sharing as valuable tools to improve communication, knowledge, and usefulness |
| 12118 | Support the development of a collaborative, national consumer medicine safety and education program to better equip consumer and caregivers to recognize and report medication-related errors |
| 12119 | Develop a memorandum of understanding to organize and support a collaborative, national consumer medicine safety and education program modeled after the partnership for food safety education |
| 12120 | Disseminate initial campaign messages by October 1999 to coincide with the 134th national "Talk about Prescriptions" month, which could be reformulated as "National Medicine Safety and Education Month" |
| 12121 | Participate with consumer organizations, industry groups, and other stakeholders in the "National Medicine Safety and Education Month" by contributing resources towards collaborative message design, testing, implementation, and evaluation |
| 12122 | Develop a sustained national consumer education program |
| 12123 | Provide consumer access to full information about all medicines |
| 12124 | Allow direct-to-consumer advertising that is educational about the availability of prescription drug therapies for specific medical conditions, rather than direct-to-consumer advertising of specific prescription drug products |
| 12125 | Continue to make package insert information available by way of the Internet |
| 12126 | Make package insert information available on the Internet for drug products approved before January 1998 as well as those approved after that date |
| 12127 | Provide a fax-on-demand service for access to package inserts, postmarketing surveillance data, and special alerts |
| 12128 | Provide a widely publicized hotline for telephone access to information from consumers and professionals |
| 12129 | Keep Internet information on approved drug products up to date and expanded with respect to unlabeled uses |
| 12137 | Develop specific criteria to be determined and consumer tested and evaluated for what constitutes useful accompanying patient education information in conjunction with direct-to-consumer advertisements |
| 12138 | Engage in promotion and advertising about FDA's website |
| 12141 | Make available to private sector organizations information and data obtained by FDA in consumer focus groups and research surveys to encourage them to build and develop their own research base |
| 12150 | Make basic information readily available |
| 12151 | Develop methods for candidly presenting approval issues to the public |
| 12152 | Review more stringently the content and level of information provided in direct-to-consumer advertising |
| 12153 | Revisit the Congressional mandate for a private sector solution for providing consumers and patients with information about prescription drugs mandated by Public Law (PL) 104180 |
| 12154 | Begin immediately a process of review of the quality of written prescription drug information being provided to consumers and patients in preparation for the year 2000 evaluation as stated in PL 104180 |
| 12155 | Provide educational resources for patients and providers |
| 12156 | Use the Centers for Education and Research (proposed for NIH) to support patient-oriented, post-approval research and to improve prescriber education |
| 12162 | Develop and support an infrastructure to communicate quality, objective drug information to the public and prescribers |
| 12163 | Support the United States Pharmacopeia Drug Information (USP-DI) |
| 12164 | Develop an Internet-based drug label database |
| 13016 | Allow companies and other groups to provide well-documented information on marketed drugs using market forces |
| 13018 | Work with the pharmaceutical industry to educate Congress, the press, and the public about the vast amount of safety activities already in place |
| 13028 | Educate the public about benefit-to-risk ratios |
| 13037 | Give industry an opportunity to present its viewpoints and its perspectives to the field staff |
| 13069 | Continue efforts to enhance information on FDA's home page, adding search capability and better links and organizations |
| 13071 | Continue efforts toward more open communication between the FDA, consumer groups, and professional societies |
| 13072 | Expand an effective communication policy to all levels of FDA and CBER by reexamining the current practices for working with the regulated community and other groups |
| 13073 | Work with the regulated community in a more open style of addressing issues by directing our approaches toward resolution as partners |
| 13120 | Allow industry some discretion to tailor disclosures to appropriately give the healthcare professional the information about what the specific limitations are, or the specific problems, or information in the article that is dealing with off-label uses |
| 13128 | Follow the intent of Section 114 of the statute in the drafting of the guidance on dissemination of economic information |
| 13151 | Allow the FDA Office of Consumer Affairs to manage solutions to patient and physician outreach and coordination of information |
| 13162 | Give industry guidance on how they could help preserve the current collaborative interactions |
| 13163 | Give industry guidance on how it can give FDA a better heads-up on questions and issues that it might find necessary to discuss |
| 14016 | Communicate and conduct outreach more efficiently by collaborating with the American Association of Swine Practitioners (AASP) and other similar organizations |
| 14042 | Release information on: kinds, amounts, and methods in places of delivery of antimicrobials used at sub-therapeutic and therapeutic levels in food animals (i.e., livestock, poultry, fish and other food animals) in the U.S. |
| 14043 | Release information on surveillance and monitoring of the use of antibiotics in animal agriculture and the emergence of antibiotic-resistant animal and human pathogens |
| 14049 | Tap into the resources of the industry and continue to build partnerships (e.g., using the National Pork Producers Council's (NPPC's) extensive network of communication and educational contacts) |
| 14077 | Post all product information on the web site |
| 14078 | Target key industry persons who can provide alerts on new products that are in the pipeline to the Federal Register and have already been approved by the FDA |
| 14085 | Use the professional and commodity groups to help educate and communicate to the end users |
| 15001 | Move maximum number of resources to the goal of education, communication, and dissemination of information |
| 15020 | Refer inquiries about new products, new drugs, etc. to appropriate parties, (e.g., professional societies, companies, etc.) in order to maximize information about new products |
| 15021 | Consider listing hyper-links on Internet sites to trade organizations, associations, etc so that parties with interests in new products can easily connect |
| 15044 | Communicate more vigorously with the public through libraries, volunteer groups, schools, and tell the public what they need to know and what to ask their physicians |
| 15046 | Employ more plain language on device labels so that the lay public understands proper device use better |
| 15048 | Fund and empower the Office of Women's Health to develop an expanded outreach program that provides understandable information on adverse events and injuries |
| 15049 | Make risk and safety data and statistics available to the public via the 800 Consumer Information Line |
| 15069 | Communicate more with professional societies and other organizations. |
FDAMA Objective: C
Implementing inspection and postmarket monitoring provisions of this Act.
| 11001 | Be a leader in food safety, (i.e., leadership in science, setting standards, evaluating state programs, certifying inspectors) |
| 11002 | Respond to state requests for assistance in a timely manner |
| 11004 | Reassemble the HACCP core committee to determine whether a universal HACCP regulation for food processing industry is warranted |
| 11005 | Redirect resources for economic fraud and mislabeling issues |
| 11006 | Work with state programs to monitor imported foods |
| 11007 | Devote more attention to imports while letting the states deal with domestic concerns |
| 11008 | Develop a vertically integrated national food safety regulatory system |
| 11014 | Focus on HACCP implementation for shellfish |
| 11015 | Develop program evaluation criteria and training to ensure consistency and uniformity in state shellfish programs |
| 11016 | Nurture relationships in cooperative programs through HACCP implementation and state shellfish programs |
| 11022 | Educate all food handlers in the distribution chain on food safety practices |
| 11025 | Strengthen the Center for Food Safety and Applied Nutrition's (CFSAN's) leadership role in Codex activities |
| 11032 | Work to harmonize the regulation of the global food supply |
| 11033 | Increase resources for Codex activities |
| 11034 | Modernize food standards |
| 11035 | Exercise a visible and effective enforcement presence where there is egregious economic fraud, such as in the adulteration of high-value juices |
| 11036 | Apply HACCP regulations to fishing vessels that do not process their catch |
| 11040 | Play an active role in Codex to ensure that international standards and guidelines are consistent with U.S. requirements |
| 11041 | Move aggressively to negotiate effective international agreements for on-site seafood HACCP inspections |
| 11042 | Enhance oversight of economic violations |
| 11048 | Take action against deceptive label claims |
| 11052 | Safety and labeling standards should be harmonized in an upward fashion to reflect the best consumer protection and public health requirements |
| 11053 | Do not eliminate food standards |
| 11060 | Renew contract with the Food Chemicals Codex |
| 11065 | Promote harmonization |
| 11066 | Improve leadership in the Codex |
| 11069 | Reverse the decision to cancel inspection and compliance programs for cosmetics |
| 11070 | Be a leader internationally in the harmonization of regulatory requirements for cosmetics |
| 11074 | Move towards a voluntary HACCP-based system for dairy products, away from checklist inspections and prescriptive plant processing regulations |
| 11075 | Reduce consumers' risk from imported foods |
| 11080 | Expand the In Flight Food Service Association-FDA HACCP pilot project to other FDA regions |
| 11081 | Use the In Flight Food Service Association-FDA HACCP pilot project as a model for HACCP retail |
| 11084 | Improve handling of adverse event reports to involve the industry earlier when problems are identified |
| 11085 | CFSAN should continue work in risk assessment and international activities |
| 11088 | Improve the handling of adverse event reports |
| 11089 | Work closer with the industry on postmarket surveillance and tracking of adverse reaction reports when problems arise |
| 11090 | Mandate that fruit and vegetable juices be pasteurized or otherwise processed to ensure their safety |
| 11091 | Implement HACCP regulations for foods with a demonstrated high risk, (e.g., unpasteurized juice) |
| 11093 | Improve international food safety standards through cooperation in Codex |
| 11094 | Promote national uniformity and harmonization among federal and state agencies |
| 11095 | Continue the food standards program |
| 11096 | Prevent economic fraud |
| 11101 | Target programs that ensure that consumers know what they are buying and act decisively in cases of mislabeled products |
| 11104 | Continue to strengthen the efforts surrounding dietary supplements |
| 12002 | Create a new classification system for prescription pharmaceuticals |
| 12003 | Seek to ban the practice of sampling and replace it with a system that can facilitate starter doses through normal distribution mechanisms |
| 12007 | Work more effectively and proactively with prescribers and pharmacists to promote swift reporting of all adverse effects |
| 12008 | Encourage manufacturers to utilize the latest notification technology to report adverse events |
| 12013 | Create a new clear understanding of CDER's relationships to the districts and the regions regarding inspections |
| 12014 | Communicate the relationship between CDER, the districts, and regions down to the consumer level, or at least to State and local regulatory levels |
| 12015 | Devote more time to the inspection process to allow for more comprehensive rather than just product-specific inspections |
| 12016 | Focus district inspections on the health impact of the regulations, not just the "black and white" of the regulations |
| 12018 | Perform periodic quality inspections and laboratory analyses for identity, potency, and purity to ensure that quality of drugs in foreign countries equals ours. |
| 12019 | Have equivalent standards in foreign countries and effective regulatory programs as well |
| 12020 | Expend more time in foreign oversight and use the states to cover domestic regulatory oversight at their level |
| 12028 | Direct emphasis toward decreasing the number of adverse events, then secondly concentrate on the passive reporting system |
| 12029 | Give consideration to mandatory reporting in hospitals similar to the medical device reporting requirements |
| 12031 | Consider regular continuous reminders to health care professionals and regulators about a critical outcome associated with FDA; usually only one message is received from FDA |
| 12032 | Improve the MedWatch report with better exchange of information with the states and the industry (e.g. reports to states on a continuous basis and reports to FDA on a continuous basis) |
| 12039 | Interact more with states to include joint work planning and areas of shared responsibilities |
| 12040 | Incorporate into the Centers models of interaction with the states that exist in the FDA regional offices |
| 12041 | Focus attention on imports |
| 12042 | Review and update the personal use policy to address concerns and complaints related to the quality of these products and the probability of diversion into normal commerce |
| 12047 | Take a more comprehensive approach in the management and coordination of Good Manufacturing Practices (GMP) inspections |
| 12048 | Involve different parts of the FDA, along with regulated industry, in a collaborative effort aimed at assuring an efficient and effective inspection program |
| 12056 | Work with the pharmaceutical industry, patients, doctors, pharmacists, hospitals, Congress and anyone else to monitor the safety of medicines after marketing |
| 12077 | Create a system or category for drugs that need monitoring, so that when the pharmacist and physician are ordering them, the system prevents a patient from getting a second refill until necessary tests are done |
| 12078 | Require reporting so that we could get more denominator data from the adverse drug reactions (ADRs) |
| 12079 | Apply resources to collect pharmaceutical statistics when a specific issue arises |
| 12083 | Create a more tightly controlled system and better record keeping on some of these products (e.g. anabolic steroids) so we can know where they are being used |
| 12088 | Allow PhRMA to help the Agency design a program of first-party audits with benefits for both participating firms and the Agency |
| 12090 | Find a way in which the Agency is comfortable sitting down to discuss first- and third-party audits |
| 12091 | Encourage the states to try and follow models/statutes that mirror the federal statute |
| 12092 | Improve state contract program and incorporate other states into those arenas that don't have formalized contracts or partnerships |
| 12094 | Sort out the blame when a failure of a drug product occurs |
| 12095 | Develop systems to target which drugs should be monitored and for which drugs information should be collected |
| 12096 | Stimulate large health insurers to get ADR information back to companies and then out of the companies and back to the FDA |
| 12097 | Measure success not only by the number of drugs and devices approved, but also by a reduction in number of deaths, adverse reactions, and recalls reported |
| 12101 | Create an Office of Drug Safety |
| 12108 | Request more resources for more aggressive policing of ad content |
| 12110 | Make the public aware when companies have been asked to revise or pull ads, and explain why |
| 12129 | Keep web information on approved drug products up to date and expanded with respect to unlabeled uses |
| 12130 | Consider ways to allow anonymous reporting to the MedWatch program |
| 12131 | Schedule MedWatch communications about specific problems several times per year in addition to special alert notices for urgent circumstances |
| 12132 | Formally adopt a standardized taxonomy of reportable events if such is developed by the National Coordinating Council on Medication Error Reporting and Prevention |
| 12133 | Remain open to the possibility of redefining terms such has "Medication Errors," "Adverse Drug Reactions" and "Adverse Drug Events" if these are standardized by other interested parties |
| 12135 | Continue to allow access to MedWatch database by others, with appropriate shielding of confidential aspects |
| 12136 | Prioritize analysis of the MedWatch database |
| 12139 | Have regularly scheduled appearances of the MedWatch alert so people will begin to anticipate them and appreciate the information |
| 12140 | Have periodic summaries of the safety alerts that are issued as the events occur |
| 12145 | Create an Office of Drug Safety to fulfill surveillance and adverse event reporting in CDER |
| 12146 | Compel drug sponsors to conduct post-approval trials that are agreed upon at the time of approval, especially for priority drugs |
| 12147 | Develop a stronger system for compelling sponsors to conduct controlled studies, to confirm clinical efficacy, and to expand the limited knowledge base that formed the basis for approval |
| 12148 | Ensure that reports on individual, post-approval studies provide information that has sufficient detail to be meaningful |
| 12157 | Increase the drug safety staff |
| 12159 | Make postmarketing safety decisions independent from the medical review process |
| 13008 | Use PDUFA II extra funding to streamline adverse reporting and data analysis |
| 13009 | Work with stakeholders on streamlining adverse reporting and data analysis as issues are identified |
| 13019 | Work with the pharmaceutical industry, patients, doctors, pharmacists, hospitals, Congress and others to improve the system for monitoring the safety of medicines after they are on the market |
| 13023 | Collaborate with other regulatory agencies worldwide |
| 13049 | Rewrite the GMPs in a comprehensive manner to incorporate the 200, 600, and 800 series regulations into one set of unified regulations for blood and plasma products |
| 13050 | Perform analyses and trend reporting on error and accident reports and make this available to the industry |
| 13051 | Develop a more rational recall and withdrawal policy to save Agency resources |
| 13058 | Examine historical experience with the current error and accident reporting system before extending it to other areas |
| 13065 | Analyze for and identify the lowest common denominator in areas where CBER, the Center for Devices and Radiological Health (CDRH) or CDER regulate similar technologies for similar uses, and use this to develop a more unified approach to regulatory policy and enforcement |
| 13067 | Analyze the risks and benefits of the European community's policy toward blood processing solutions as device accessories versus drugs |
| 13068 | Continue international harmonization efforts until a single global dossier is recognized for all blood and plasma products, related drugs, and devices |
| 13074 | Continue interaction with work groups such as the CFRR to seek resolution of outstanding issues such as those relating to adverse reactions, errors and accidents, and product retrievals |
| 13078 | Think more innovatively about providing clear guidance about the requirements for the new annual report process |
| 13081 | Think more innovatively about expanding the regulations to directly reference blood and blood products instead of trying to fit them into a system with which they do not harmonize |
| 13086 | Expand public input into the error and accident reporting program beyond the regulated community that would be submitted to an independent agency and shared among the regulated community |
| 13088 | Move toward global regulation of blood and blood technology products |
| 13125 | Permit Internet reporting for some of the reporting requirements under the statute |
| 13146 | Continue to consider supply while ensuring that the manufacturers are in compliance with GMPs |
| 13147 | Stagger inspections |
| 13149 | Phase in inspections and allow lot release while improvements are being made |
| 13167 | Create a system to handle shortage and allocation strategy |
| 14005 | Direct more effort toward preventing distribution of illegally marketed or compounded products, and those practices that are outside the provisions of the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) regulations |
| 14007 | Find a way to avoid having two separate people (i.e., field investigator and center compliance officer) perform a science and Current Good Manufacturing Practice (CGMP) compliance review of voluminous data (i.e., less amount of time and greater consistency) |
| 14009 | Avoid third-party efforts at this time |
| 14010 | Examine how surveillance and compliance resources are used on companies marketing properly versus companies that are marketing illegally or compounding improperly (e.g., mail-order pharmacies) |
| 14011 | Increase enforcement in the area of illegal distribution of prescription drugs to end users without authorization from a veterinarian in a valid veterinarian/client/patient requirement |
| 14013 | Have compliance and surveillance staffs consider it a priority to provide information on AMDUCA to the American Veterinary Medical Association (AVMA) journal |
| 14015 | Educate third parties and help them understand Veterinarian-Client-Patient Relationship (VCPR) if they are used for surveillance or compliance work |
| 14017 | Seek voluntary restrictions on post-approval monitoring programs for antimicrobial resistance rather than regulatory approaches |
| 14028 | Simplify the post-approval updates to the manufacturing section of the approved applications (i.e., changes to the manufacturing process) |
| 14029 | Delete from the annual drug experience report the section which calls for any updates in the manufacturing; instead, submit biannual AAP updates (Alternative Administrative Procedure for submitting manufacturing chemistry changes) on minor changes and supplements to the New Animal Drug Application (NADA) for major changes |
| 14039 | Consider developing a nationwide post-approval monitoring program [re: antibiotic resistance] |
| 14050 | Clarify the process of developing enforcement strategies by the Office of Surveillance and Compliance and involve stakeholders |
| 14059 | Make international harmonization an important issue for the long term |
| 14068 | Redirect resources more towards surveillance and perhaps less toward the drug approval process |
| 14075 | Develop an appropriate monitoring mechanism to ensure violative residues do not occur in imported products |
| 14080 | Make enforcement a high priority, especially in the case of bovine spongiform encephalopathy (BSE), transmissible spongiform encephalopathies (TSE), and the rendering industry |
| 14082 | Collaborate with USDA to develop a fool-proof system to ensure animals that exhibit neurological disorders do not reach the food supply |
| 14084 | Focus strong enforcement and compliance activities on the industry's ne'er-do-wells |
| 14087 | Increase oversight of the field offices by headquarters |
| 14088 | Fully fund state programs under contract with GMP inspections |
| 14089 | Create a voluntary self-inspection program to ensure appropriate scientific infrastructure |
| 14094 | Place high priority on voluntary self-inspection programs for medicated feed establishments |
| 14099 | Focus on international issues, such as regulation of imported products and Codex, import inspections for safety and purity, food and feed safety standards |
| 14101 | Review the frequency of inspections; in a given period, some establishments are inspected three times while others are not inspected |
| 14102 | Focus inspections on food safety |
| 14103 | Work continuously to improve the safety of the food supply |
| 14105 | Set science-based feed safety standards |
| 14107 | Include safe manufacturing of feeds and accurate labeling, while guarding against contamination in the feed safety program |
| 14108 | Include manufacturing process controls in the safe production of medicated feeds |
| 14109 | Use voluntary self-inspection, or self-certification through self-inspection of manufacturing of animal feeds, with third-party involvement in certification and oversight |
| 14110 | Develop more coordination and/or understanding between state and federal programs regarding animal feed regulations |
| 14111 | Police fraud and mislabeling of animal feeds |
| 14112 | Use co-training programs when contracting with the states to improve inspection processes |
| 15002 | Use the Internet to help with international compliance issues |
| 15003 | Implement accredited formal training programs for members of the device industry who teach manufacturers what they need to do |
| 15006 | Partner with third parties to do routine inspections and allow FDA to concentrate more on its scientific role |
| 15008 | Partner non-critical conformance roles with third parties through accreditation by FDA |
| 15010 | FDA should continue to conduct postmarket studies at all costs. These studies cannot be privatized, and the public expects the Agency to have complete control over them |
| 15011 | Create a separately funded center, if necessary, for the analysis and coordination role of postmarketing studies |
| 15012 | Maintain a very strong handle on establishment registration, especially regarding international and transjurisdictional issues |
| 15013 | Include ISO 13485 in the ongoing accredited persons program for Quality System Regulation (QSR) inspections |
| 15014 | Develop a 2- to 5-year plan to move to a full QSR credit for ISO 13485 |
| 15015 | Rethink the advent of conformity assessment bodies (CABs) |
| 15016 | Do not seek application of the HACCP process for device conformance |
| 15022 | Consider development of International Standards Organization (ISO) certification of companies by third-party review |
| 15023 | Streamline inspections so they are more focused, take less time, and so that the company understands FDA expectations |
| 15024 | Create an industry/FDA/User facility working group to look at the design (i.e., goal, vision, structure) of the Sentinel System and the funding strategies for it |
| 15025 | Utilize summary reporting to a greater degree for Medical Device Reports (MDRs) |
| 15026 | Streamline the postmarket surveillance program to have an achievable purpose and reduce the number of subject products |
| 15028 | Apply postmarket tracking to products that really require it based upon a validated risk model and seek stakeholder involvement when identifying these products |
| 15030 | Consider mechanisms for ISO certifications and/or an accreditation process for "controlling" not "conducting" the inspection process |
| 15031 | Include partial credit for ISO certifications in the accredited person program in order to level the playing field with foreign device manufacturers |
| 15032 | Consider having devices in lower risk categories be candidates for the first phases of devolution of inspection duties towards third parties in the accredited persons program |
| 15035 | Return to an adequate inspection program in the area of radiation control to protect the public health from unnecessary exposure (i.e., resurrect the States program) |
| 15036 | Develop a Mammography Quality Standards Act (MQSA) approach to other diagnostic radiological tests |
| 15038 | Consider the State radiation control programs' needs when re-engineering FDA-required reports |
| 15043 | Require physicians to report adverse device experiences |
| 15050 | Explore a process for the efficient capture and utilization of adverse event data by FDA and the clinical community |
| 15057 | Explore an incident reporting system operated by an outside agency (i.e., Federal Aviation Administration model) alongside and in addition to the sentinel reporting system |
| 15060 | Maintain the Federal Compliance Testing program for diagnostic x-rays |
| 15066 | Stratify inspections based upon past history of compliance of companies, degree of risk of the product, and various other elements that FDA has built into its plan |
| 15075 | Eliminate the inspection program for x-ray machines and put the onus on the facility buying the equipment to hire a medical physicist to inspect it and report the results to FDA |
| 15083 | Conduct follow-up studies on persons who have grandfathered devices to help identify any associated problems or symptoms |
| 15085 | Explore the idea of using real practitioners and ultimate end users, consumers in every form, to help evaluate incident reports |
| 15086 | Consider going for the full anecdotal story, not just a summary report, to allow analysis of patterns within the stories |
| 15088 | Monitor better what pharmaceutical industries put out and what they monitor |
| 15089 | Find qualified volunteers to help monitor what goes in inserts and on boxes. |
FDAMA Objective: D
Ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1).
| 11001 | Be a leader in food safety, (i.e., leadership in science, setting standards, evaluating state programs, certifying inspectors) |
| 11003 | Adequately fund and staff research |
| 11015 | Develop program evaluation criteria and training to ensure consistency and uniformity in state shellfish programs |
| 11018 | Use science and fact-based risk assessments |
| 11026 | Perform research into the development and application of methods to quantify exposure and risk |
| 11027 | Use sound science and risk assessment when making decisions on prioritization of food safety issues |
| 11028 | Focus research efforts on emerging foodborne pathogens, quantitative risk assessment, practical detection methods, faster analysis, and identification of sources and the means of prevention of contamination in foods with pathogens |
| 11029 | Work cooperatively and fill gaps through resources outside the FDA |
| 11039 | Focus research on risk assessment and methods development, equally |
| 11050 | Reconstitute the Food Committee to increase its credibility and to include consumer activists for balance |
| 11059 | Continue consultation program for biotechnology products |
| 11077 | Focus on health-related product labeling, particularly updating standards of identity and review of health claims petitions |
| 11078 | Perform research or modeling in the areas of infectious dose for pathogens because zero tolerance does not always reflect the current scientific information |
| 11085 | CFSAN should continue work in risk assessment and international activities |
| 11086 | Establish a dietary supplement Advisory Committee |
| 11087 | Place a high priority on nutrient databases |
| 11102 | Adopt a science-based policy on health claims and labeling |
| 12075 | Fund new research for developing surrogate markers in fast-track diseases that have no surrogate markers at present |
| 12158 | Leverage access to other sources of information, such as working with the PBMs, to look at concomitant drug prescriptions |
| 12160 | Expand regulatory research on safety factors |
| 12165 | Continuously educate the Agency staff about state-of-the-art science, mentor new recruits, and retool senior staff |
| 12166 | Develop a program to bring academic scientists to the Agency |
| 12169 | Use national search committees when filling important positions |
| 12170 | Develop a sabbatical program |
| 12171 | Ensure that Advisory Committee members have the adequate skill level necessary |
| 12172 | Include at least one clinical pharmacologist and one biopharmaceutical scientist on every Advisory Committee |
| 12173 | Develop opportunities, as through sabbaticals, for the Agency, academia ,and the industry to share ideas |
| 13004 | Create a mechanism for the Agency to receive sound advice on scientific questions |
| 13005 | Convene a working group from the regulated industries to review present Agency use of Advisory Panels and make recommendations as to how the process might be improved to maximize their utility to the FDA |
| 13010 | Make regulatory decisions, including the development of guidance documents and regulations, on the best available science |
| 13011 | Work more closely with industry to identify research areas and review ongoing programs |
| 13020 | Conduct targeted research on regulatory policy, particularly if planned collaboratively with industry |
| 13021 | Provide in-service training that supports the skills of staff to conduct reviews of marketing applications |
| 13022 | Train field staff partly within pharmaceutical companies |
| 13023 | Collaborate with other regulatory agencies worldwide |
| 13024 | Establish periodic meetings for Division Directors in both CBER and CDER with up to four industry representatives on a bimonthly or quarterly basis to share scientific and technical information, management ideas, overall approaches, and creative thinking |
| 13027 | Give reviewers brief sabbaticals in the regulated industry |
| 13033 | Have CBER talk with CDER about the success of the program for brief sabbaticals in the regulated industry |
| 13052 | Conduct research in CBER for maintaining an appropriate scientific infrastructure |
| 13066 | Convene external advisory groups to help eliminate the differences where differences among regulatory policies exist between centers for similar projects (e.g., computer programs) |
| 13067 | Analyze the risks and benefits of the European community's policy toward blood processing solutions as device accessories versus drugs |
| 13068 | Continue international harmonization efforts until a single global dossier is recognized for all blood and plasma products, related drugs and devices |
| 13075 | Reevaluate requirements for participation, as appropriate, by national FDA staff in professional meetings that are sponsored by the regulated community or other non-government entities to allow for more participation |
| 13080 | Think more innovatively about creating a system for making quick changes to guidance documents as scientific and technical knowledge expands, without compromising the public input process |
| 13085 | Set up staff exchange programs with academia, other government agencies such as NIH, the Centers for Disease Control and Prevention (CDC), the National Science Foundation (NSF), and industry research organizations, to share staff expertise, and research results |
| 13133 | Use experts to evaluate the substantiation and the information, whether it is modeling, or meta-analysis |
| 13134 | Carry throughout the Agency CBER's model of using science as the basis for pulling together guidance documents and regulations |
| 13153 | Configure Advisory Committees to have consumer representatives as an essential component in the FDA regulatory process |
| 13154 | Continue to use consumer advisors |
| 14003 | Find ways to improve or fill human resource gaps in application review processes by seeking expert outside review of certain sections of the application |
| 14004 | Consider using outside expertise on statistical evaluation of efficacy studies |
| 14012 | Conduct transparent science-based discussions with stakeholders regarding the results of antimicrobial susceptibility monitoring programs and determining corrective actions |
| 14014 | Seek scientific input from external (non-FDA) groups and organizations in order to make sound decisions; develop a mini-working group to do this |
| 14018 | Use a public process to identify criteria for antibiotic approvals and the thresholds for antibiotic resistance |
| 14019 | Secure from the animal drug companies information as to the quantity of antibiotics sold in the U.S. by label |
| 14021 | Have consumer representatives sit at the table with the scientists and other stakeholders to define the criteria by which an antibiotic is approved and to identify thresholds for antibiotic resistance |
| 14023 | Seek to establish a database with complete and accurate (e.g., pounds of feed sold and active ingredient per pound) information to monitor microbe-related illnesses and trends in antibiotic resistance |
| 14036 | Correlate antibiotic use with developing resistance in order to make public health policy decisions |
| 14051 | Work closely with USDA and Agriculture Research Service, and cooperative extension to ensure that FDA's science needs are met |
| 14063 | Stand firm on science, including risk-benefit analysis, in evaluating submissions, in collaborative problem-solving, and in education |
| 14064 | Foster close relationships with USDA, research and education agencies to ensure science and technology transfer needs are met |
| 14066 | Focus on problem identification and problem solving, and technology transfer; the industry has quality assurance and monitoring programs |
| 14067 | Engage stakeholders and other government agencies regarding intramural research programs and funding |
| 14069 | Re-establish the pet food specialists in CVM |
| 14086 | Give enhanced training and education for the inspectors and reviewers, possibly through joint industry-Agency efforts |
| 14105 | Set science-based feed safety standards |
| 14106 | Devote necessary resources for development, or selection and validation where needed, of analytical methods for detection, especially of certain potentially high-risk feed contaminants in the name of feed safety. |
| 14117 | Update the capabilities of CVM's scientific reviewers |
| 14118 | Have the CVM Advisory Committee examine a broad range of issues, not just clinical |
| 15004 | Develop a subcontractor network for broadening scientific input |
| 15005 | Move some of the expert resources from non-critical inspection duties to serve on FDA advisory or other types of committees |
| 15039 | Revisit the structure and number of FDA Advisory Committees in order to increase the number of participants, broaden the committee's mission and increase the total number of committees |
| 15042 | Partner (i.e., non-regulatory) with radiological stakeholders to develop a more standardized, quality approach to medical imaging in order to achieve proper patient diagnoses |
| 15058 | Make consumer representatives on Advisory Panels an integral part of the process from the beginning |
| 15062 | Prepare the consumer representative on Advisory Panels for their role and be invested in helping them overcome the technical and cultural barriers |
| 15069 | Communicate more with professional societies and other organizations |
| 15078 | Review products on the merit of scientific evidence, safety and effectiveness, and not on politics as supported by adverse reporting statistics |
| 15087 | Develop a fund for public citizens to come and testify before Advisory Panels. |
FDAMA Objective: E
Ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1).
| 11023 | Streamline the process for approval of food and color additive petitions |
| 11047 | Promptly approve well-founded health claims that would promote an overall healthier diet |
| 11056 | CFSAN should conclude its review of GRAS petition 3G0016 regarding GRAS affirmation for many enzymes used in biotechnology |
| 11058 | Replace the resource-intensive GRAS petition process with a streamlined notification system |
| 11061 | Focus priority on the approval of new food additives and approval of additional uses of approved food additives |
| 11063 | Develop a simplified GRAS notification procedure, in addition to the current procedure |
| 11064 | Expedite the approval of appropriate nutrient content and health claim petitions and citizen petitions related to food labeling |
| 11067 | Significantly improve the food additive approval process to increase efficiency, predictability, and accountability |
| 11092 | Reform the food additive review process |
| 11098 | Initiate a pilot study by taking petitions or a threshold of regulation requests from the current backlog and processing them through the review portions of the proposed food contact notification program |
| 12036 | Finalize over-the-counter (OTC) monographs, with periodic reviews to update and clarify the finalized monographs pursuant to new technologies and drugs |
| 12059 | Assign highest priority for CDER and CBER to continue to expedite the development and review of new drugs for treating serious and rapidly fatal diseases such as ALS |
| 12060 | Make FDA guidance for fast-track diseases explicit |
| 12061 | Solicit recommendations for properties of fast-track diseases from both the American Medical Association (AMA) sections and specialty organizations, e.g. American Neurological Association, American Academy of Neurology, World Federation of Neurology |
| 12062 | Urge proper implementation of the FDAMA section on fast-track products to increase and expedite the availability of new therapies for ALS; ALS drug development has not benefited equally from accelerated approval |
| 12063 | Acquire substantial evidence of effectiveness for ALS drugs by permitting the use of phase IV post-approval conformance trials, and adhering to its own standards |
| 12064 | Reassess the need for controls in phase III for a disease such as ALS, which has no surrogate markers, but is relentlessly progressive and results in continuously cumulative physical impairments |
| 12065 | Consider approval based on efficacy relative to safety for ALS drugs, as with cancer drugs and immunosuppressive drugs for organ transplant |
| 12067 | Evaluate the efficacy of a drug or biological product for ALS in the fast-track approval process as for other life-threatening diseases |
| 12074 | Proactively plan the future drug approval process for fast-track diseases and formalize and implement those plans |
| 12102 | Work with industry to ensure the integrity of the clinical trial process |
| 12111 | Have an independent consumer-run organization, funded by pharmaceutical companies, to independently evaluate drugs advertised to consumers |
| 12134 | Make failure mode and effects analysis a requirement for all drug product approvals |
| 12149 | Ensure that all applications reviewed under the fast-track provisions of FDAMA be subject to all provisions of that section |
| 12158 | Leverage access to other sources of information, such as working with the PBMs, to look at concomitant drug prescriptions |
| 12174 | Develop a more formalized approach to prioritizing and examining the risk-benefit of certain drugs, such as the "lifestyle-modifying" and "me too" drugs |
| 13017 | Do not overreact to the small number of recent withdrawals by slowing down the process |
| 13044 | Use the Prior Approval Supplement (PAS) process only for novel products or for a first-time request to license an establishment or product |
| 13048 | Engage industry in a dialogue about the pilot program for approval of certain blood and plasma products through a monograph system |
| 13053 | Provide quicker patient access to improved blood products and technologies through shorter review times |
| 13054 | Provide quicker patient access to improved blood products and technologies through more constructive dialogue with CBER policy staff |
| 13055 | Reduce review times for blood-related drugs, devices and products to no longer than 6 months for any review cycle, not just fast track |
| 13056 | Create goals for review times for responses to warning letters or other enforcement topics (e.g., 10-30 days from industry followed by 2-3 months for FDA review) |
| 13057 | Relegate to market withdrawal status any blood or plasma recalls involving only hypothetical risks, technical deviations or small numbers of expired products |
| 13058 | Examine historical experience with the current error and accident reporting system before extending it to other areas |
| 13060 | Reduce the extent of prior-approval work for the addition of modified blood products (e.g., irradiated or leukocyte-reduced) |
| 13062 | Downgrade some changes to 30-day notice and annual report status |
| 13063 | Integrate approval processes for new blood product license supplements with drug and device clearances |
| 13064 | Expand the use of guidance documents and notifications to facilitate licensed blood center use of new technologies where the technology has a proven track record for many years, or where the benefits clearly outweigh the risks |
| 13076 | Expedite the rapid development and completion of the new protocol comparability process and other initiatives |
| 13082 | Think more innovatively about creating an innovative staff incentive/reward system that will foster new ideas and speedier reviews without compromising quality and effectiveness |
| 13084 | Create a tier for submissions and reviews based on hazard and impact |
| 13090 | Have a classification for meetings (e.g., A, B, C) with defined timelines (e.g., 30, 60, 75 days) for holding the meeting after the request |
| 13093 | Require pre-approval for a substantial change, a 30-day review period for a moderate change to a product (a supplement with a notice), and an annual report for a minimal change (notice) |
| 13095 | Develop specific guidance dealing with tests and acceptance criteria in the process for a comparability protocol |
| 13096 | Apply PDUFA II (Prescription Drug User Fee Act) performance goals that have been stated first to fast track |
| 13097 | Exceed the PDUFA II goals when it comes to fast track items |
| 13098 | Further clarify and develop the definition of "serious and life-threatening conditions" |
| 13099 | Clarify and develop the definition of "unmet medical needs" |
| 13100 | Make use of unvalidated surrogate end points subject to the post-approval requirements of subsection (b)(2), and do not create a new grouping of post-approval requirements for fast track |
| 13101 | Allow regular approval for fast tracks when using clinical or validated end points, and do not make them subject to the post-approval requirements of subsection (b)(2) |
| 13102 | Include discussion of the selection process for surrogate end points in guidance documents |
| 13103 | Focus attention on surrogate end points for chronic or degenerative type diseases that require longer or larger clinical trials |
| 13104 | Focus attention on surrogate end points that have broader applicability to a class of technologies such as with gene or cell therapies |
| 13106 | Provide recommendations and guidance in the surrogate end points guidance document with regard to dissemination of information on surrogate end points |
| 13107 | Provide authority to Division Directors for designating products as fast track |
| 13108 | Base withdrawal of fast track designation on sponsor demonstration, via a pivotal clinical trial, that it is no longer pursuing an indication for a serious or life-threatening disease |
| 13109 | Base withdrawal of fast track designation on a complete review of the NDA or BLA by an Advisory Panel and determination that a product does not meet an unmet medical need |
| 13111 | Allow a sponsor to request fast track designation at filing of the IND, during the process, or at filing of the NDA/BLA |
| 13112 | Meet with the sponsor within the first 60 days to begin dialogue about what all the requirements would be for an IND that receives a fast track designation |
| 13118 | Terminate pre-approval of marketing literature 6 months after the product has been approved unless the sponsor is demonstrating a pattern of inappropriate promotional activity |
| 13136 | Develop a uniform set of acceptance criteria for what subset analyses would look like from the industry so there are not differences between divisions |
| 14006 | Review requirements for new animal drug applications (e.g., section 514) and see if information that has been required in the past is no longer necessary and can be eliminated |
| 14026 | Consider outsourcing some reviewing of certain application sections, e.g., human food safety section |
| 14027 | Eliminate duplication in the review process, particularly in the Chemistry, Manufacturing, and Controls (CMC) section of the submission; simplify and streamline |
| 14028 | Simplify the post-approval updates to the manufacturing section of the approved applications (i.e., changes to the manufacturing process) |
| 14029 | Delete from the annual drug experience report the section that calls for any updates in the manufacturing; instead, submit biannual AAP updates on minor changes and supplements to the NADA for major changes |
| 14035 | Require manufacturers to submit sales data, checking the amounts of the various antibiotics used in species of livestock and make the data publicly available |
| 14046 | Streamline the Biometrics staff review and eliminate needless number crunching that causes inefficiency in the review process |
| 14047 | Refocus on the intent of the legislation behind the Animal Drug Availability Act (ADAA) and fulfill its mission statement, i.e., timely review through better communication and clarification |
| 14048 | Make delegation of responsibility to third parties an open process with stakeholder involvement |
| 14053 | Streamline the efficacy review process even more; it is still at odds with the reality of modern animal agriculture |
| 14055 | Make good use of the formal binding presubmission conferences to reduce backlogs and speed the approval process |
| 14056 | Establish an effective minor use/minor species program through administrative not legislative means |
| 14058 | Ensure implementation of ADAA by reducing the approval time, increase staffing levels, and providing adequate funding before raising the User Fee issue |
| 14065 | Use formal presubmission conferences |
| 14070 | Work with the industry and the aquaculture industry to increase the availability of aquaculture drugs |
| 14071 | Forward to Congress the proposal to increase the availability of approved animal drugs for minor species and minor use, as originally written by CVM |
| 14074 | Promote international drug harmonization for animal drug approvals |
| 14079 | Make new product availability a priority |
| 14092 | Emulate CFSAN's proposed GRAS notification system to sanction more feed products and ingredients |
| 14093 | Reduce the complexity of the drug review process |
| 14098 | Expedite review and action on citizen petitions filed by interested parties seeking changes in the Agency's rules or procedures, especially those concerning animal drug assays, liquid feeds, and GMPs |
| 14114 | Make efficacy studies flexible |
| 15007 | Transition to a European model for premarket approval over five years |
| 15009 | Adopt the identity of a competent authority to administer the role of third parties (notified bodies) for the market placement of devices |
| 15029 | Create an FDA/stakeholder working group to identify additional mechanisms to meet submission time frames |
| 15037 | Continue to offer FDA reviews as an alternative to third-party reviews |
| 15070 | Add more devices to the list for third-party review and make the process for using third-party review more clear. |
FDAMA Objective: F
Eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1, 2000.
| 11062 | Increase attention to the affirmation of long-pending GRAS petitions |
| 11098 | Initiate a pilot study by taking petitions or a threshold of regulation requests from the current backlog and processing them through the review portions of the proposed food contact notification program |
Not Directly Related to a FDAMA Objective
| 11009 | Give priority to product safety assurance and outreach, including the programs that support these activities |
| 11010 | Place high priority on programs that affect the health of the general population |
| 11011 | Place priority on research for alternative indicators; rapid methods for specific pathogens; biotoxin identification; and risk-assessment |
| 11012 | Place priority on international activities, especially the safety of imported thermally processed shellfish, the effectiveness of processing practices, and the adequacy of biotoxin monitoring in foreign countries |
| 11013 | Focus on food safety issues that relate to economic fraud |
| 11017 | Develop a uniform, consistent approach to address risks of public health significance |
| 11019 | Adopt flexible and responsive regulations that encourage research and innovation |
| 11020 | Recognize that industry is responsible for the integrity of its products |
| 11021 | Seek clear, consistent, and performance-based regulations |
| 11024 | Modify food standards that are out-of-date and inhibit innovation |
| 11031 | Focus on health contributions in the diet for maintaining health and preventing disease |
| 11037 | Make research and education the highest priority for CFSAN, in cooperation with academia and industry |
| 11043 | Keep the Food Safety Initiative (FSI) as the top priority |
| 11044 | Consider the health impact of the FSI programs |
| 11045 | Improve the nutritional quality of the American diet |
| 11046 | Improve nutrition labeling to include trans-fat on the label |
| 11049 | Build a record detailing the need for greater authority to protect the public from unsafe and misleadingly labeled products |
| 11051 | Do not let trade concerns supercede health concerns |
| 11054 | Impose registration fees on food manufacturers |
| 11055 | CFSAN should publicize the fact that it cannot adequately do its job without additional resources |
| 11057 | Finalize the GRAS notification regulation |
| 11071 | Give priority to the cosmetics and colors program |
| 11072 | Apply resources to programs that minimize consumer deception |
| 11073 | Obtain adequate research funding |
| 11079 | Place more resources on Codex participation and other international activities |
| 11082 | Approve irradiation of sprouts to eradicate Escherichia coli O157:H7 and Salmonella |
| 11083 | Approve more antimicrobials to help ensure food safety |
| 11100 | Require all fresh juice processors to pasteurize or otherwise process their products |
| 11107 | Consider requiring consumer research as a component of substantiation files for dietary supplements |
| 11108 | Place high priority on threshold of regulation determinations for food packaging and certificates of free sale |
| 12030 | Increase resources in CDER, place priority on MedWatch system, and better use the assets in the states to improve response to death and injuries from medicine |
| 12033 | Emphasize premarket reviews and strengthen postmarket surveillance through the use of the states resources and consideration of drug reporting similar to device reporting requirements |
| 12034 | Assign highest priority to continuing to improve the drug approval process and expedite removal of unsafe products |
| 12035 | Consider review of grandfathered drugs (e.g. ephedrine) that have never been subjected to the drug approval process |
| 12037 | Review grandfathered drugs, which could lead to improved monographs and result in much needed reclassification of some drugs |
| 12038 | Consider non-traditional drugs and their ethnic use in monographs or as a new category of medicines |
| 12043 | Modernize the public's and industry's expectation of FDA (and the state and local governments) |
| 12044 | Address FDA's ultimate responsibility to manage, and as necessary, reallocate resources to achieve statutory deadlines and other goals of FDAMA in a timely manner |
| 12046 | Don't overstate the responsibility and authority of FDA, as in the question posed, "How can we better assure that drug advertisements communicate appropriate messages?" |
| 12054 | Stress to Congress, the press, and public that current safety standards for new drug approval are significantly higher than in the past |
| 12066 | Develop surrogate markers for ALS |
| 12076 | Increase FDA's budget with the increase in NIH's budget |
| 12085 | Change the prescription blank, the drug order, that is given to pharmacists (especially to include intended use) |
| 12086 | Solicit public support for changes in the system (e.g., prescription forms) |
| 12087 | Get involved in the dialogue of the practice of medicine and pharmacy |
| 12098 | Have PhRMA work with the Consumer Federation of America to secure adequate funding to implement FDAMA in a way that will not compromise the safety of the public |
| 12099 | Have Congress give serious consideration to expanding the User Fee program |
| 12100 | Include safety goals in the FDAMA plan |
| 12104 | Don't allow postmarket activities to suffer because of premarket activities |
| 12105 | Fully exercise the role of regulator and protector by being our own strongest and most vociferous advocate for more resources |
| 12142 | Generate a realistic budget for meeting FDA's legislative mandate |
| 12143 | Work internally to ensure that FDA leadership seizes the opportunity given by Congress to document what resources the Agency needs to do its job |
| 12144 | Reassert FDA's role as a regulator with the primary responsibility to protect and promote the public health |
| 12161 | Reassess the risk-benefit analysis of lifestyle-modifying drugs |
| 12167 | Develop a program of time-limited tenure of division and office directors |
| 12168 | Use annual reviews that are quantitative and qualitative |
| 12176 | Develop a professional-judgement budget that provides the Agency's resource needs to meet its legislative mandate |
| 13001 | Use User Fees to address certain narrow programmatic problems |
| 13002 | Continue to use the appropriations process to address the public's overall interests about FDA's ability to carry out its functions |
| 13003 | Have senior management at FDA present its budgetary needs to both OMB and Congress in a realistic and forceful manner |
| 13006 | Identify outdated or vague regulations or guidance documents as early as possible |
| 13025 | Increase efficiency in the use of current resources |
| 13026 | Do not diminish the current level of full-time support staff paid through User Fees |
| 13029 | Have external Advisory Panels advise FDA on efficient administrative policies and activities |
| 13030 | Collaborate with industry as much as possible |
| 13031 | Analyze the number of INDs in the pipeline before User Fees |
| 13032 | Have one organization or a group of management consultants advise FDA on ways to structure some of the administrative changes that you are considering |
| 13034 | Disseminate information on new drugs via the Federal Register as well as the Internet |
| 13035 | Make reviewer handbooks, GRPs, etc., available as hard copy, at a price that includes all costs plus administrative fees |
| 13036 | Make GRPs, reviewer handbooks, etc., available in both electronic and hard copy, charging more for the electronic form |
| 13042 | Ensure that the paperwork reduction and regulatory efficiency goals of the BLA are maximized with its implementation |
| 13059 | Target "me too" sites and products for paperwork reduction |
| 13061 | Simplify and reduce reporting |
| 13070 | Continue the CBER open door and open telephone policies |
| 13087 | Search out ideas and innovations from other fields that might be applicable to the FDA system |
| 13116 | Apply subsection (b)(2) (alternative standards for marketing) to unvalidated data regardless of whether it was a surrogate or clinical endpoint |
| 13117 | Take other things into consideration in terms of safety and efficacy when the 95 percent standard is not met |
| 13119 | Make criteria for acceptable journal articles and reference texts less restrictive and more comparable to the criteria outlined in the statute itself |
| 13121 | Stress to Congress, the press, and the public that the current safety standards for new drug approval are significantly higher than they were in the past |
| 13122 | Leave it to the industry to ensure that the necessary information is included and do not have specific requirements as to where and how that information should be attached or presented |
| 13123 | Make OCA the Agency to give public responses to media events, much in the same way that they handled the situation with breast implants |
| 13124 | Expand the unapproved use definition to include information from sponsors' pivotal studies that were the basis for an approval |
| 13126 | Permit industry to include their Internet site address on a reprint and indicate that further information is included there |
| 13127 | Adopt as many of PhRMA's proposals as FDA finds acceptable because the Massachusetts Biotechnology Council endorses them wholeheartedly |
| 13129 | For formulary decisions, adopt a definition of healthcare economic information that includes cost analysis, cost effective analysis, and cost benefit analysis |
| 13130 | Permit manufacturers to use reasonable assumptions with the healthcare economic consequences derived from the approved indication, rather than just clinical end points |
| 13131 | For formulary decisions, allow economic information to be supported by clinical outcomes that include physiologic, anatomic ,and biologic end points; health status; quality-of-life measures; life expectancy; patient performance, satisfaction and compliance |
| 13132 | Permit industry to disseminate information in many different ways, using both printed material, computer-based material, interactive software, etc. |
| 13135 | Have a uniform personnel training program regarding changes associated with FDAMA |
| 13139 | Publish performance results on a more regular basis rather than perhaps periodically |
| 13140 | Measure the Agency's performance and allow the public to scrutinize both FDA's and industry's performance |
| 13141 | Expand the ombudsman's role to have the jurisdiction to go Agency-wide |
| 13142 | Allow the ombudsman's role to take a more proactive position in terms of hosting forums on some general issues the industry is having so that industry can collectively respond |
| 13143 | Revise the complaint review procedure |
| 13144 | Raise complaints issued against a particular reviewer to higher visibility and scrutiny |
| 13145 | Engage in data collection concerning supply as recommended by the HHS Advisory Committee on blood safety and availability |
| 13148 | Create a regulatory environment that keeps an eye on supply |
| 13150 | Remain keenly aware of the small number of manufacturers currently producing pooled-plasma derivatives and, in the case of the alpha-1 community that they are serviced by a sole supplier |
| 13152 | Have OCA work in conjunction with CBER in the arena of plasma derivatives |
| 13156 | Make certain that a national notification plan is implemented to the extent that FDA can |
| 13157 | Use the medical and scientific Advisory Committees of the plasma users coalition |
| 13158 | Address the issue of how much control FDA has over how much product the industry manufactures |
| 13159 | Try to understand the impact of a consent decree or warning letter as it relates to supply of product |
| 13160 | Consider the requirement of 1 kilo of material that is in short supply, where only 50 percent of patient needs are currently being met |
| 13161 | Figure out how to preserve the current more open, informal approach to the regulatory process |
| 13166 | Make sure that CBER reviewers and staff, especially the newer folks, really understand the importance of the open approach to communication and how it really can facilitate things in the end |
| 14002 | Direct resources to the drug approval process to maintain a system that is responsive and efficient in meeting statutory deadlines |
| 14008 | Do not consider user fees |
| 14020 | Prohibit the use of antibiotic growth promoters that are also used in human drug therapy or that may impact human health |
| 14022 | Enable the animal drug industry to make public their antibiotic sales information |
| 14024 | Call a ban on subtherapeutic use only for those antibiotics which are used in the treatment of human disease and those antibiotics that select for resistance in antibiotics used for humans |
| 14025 | Do not use User Fees because they will discourage supplemental applications for minor uses and minor species |
| 14030 | Adopt the World Health Organization's (WHO's) position and immediately terminate the uses of penicillin and tetracycline |
| 14031 | Ban the subtherapeutic use of tylosin and lincomycin |
| 14032 | Adopt the goal of having a systematic approach towards replacing growth-promoting antimicrobials with safer non-antimicrobial alternatives |
| 14033 | Do not approve for use in livestock important antibiotic classes such as fluoroquinolones that are life-saving in human medicine, especially when other antibiotics are available |
| 14034 | Require, when approvals for new antibiotics for livestock are granted, an automatic withdrawal of the drug from the market if harmful antibiotic-resistant bacteria levels are reached |
| 14037 | Make drastically reducing antibiotic usage a top priority of CVM |
| 14038 | Redirect FSI funding to help with under-funded priorities at CVM |
| 14040 | Make a major commitment to preserving susceptibility to antibiotics among human and animal pathogens |
| 14041 | Eliminate the uses of antibiotics that are least critical (i.e., subtherapeutics) and develop more non-drug solutions to growth promotion, prophylaxis and therapy |
| 14044 | Move prudently in the review of new antimicrobials for animals |
| 14054 | Make staffing decisions according to CVM's primary responsibility, i.e., to approve animal drugs and to monitor the compliance in their distribution and use |
| 14057 | Ensure the ADAA is implemented in a manner consistent with its passage before exploring the User Fee issue |
| 14060 | Put safety first, product quality second, then efficacy issues |
| 14061 | Use more regulatory approaches rather than legislative approaches for minor use/minor species |
| 14062 | Publish a document for public comment on the categorization of sheep as a minor species |
| 14073 | Address aquaculture's need for antibacterial compounds, antifungal compounds, parasiticides, extra-label use of medicated feeds for minor species |
| 14081 | Respond to the Atlantic Monthly article on BSE |
| 14083 | Become more informed about how the real world works in order to make better decisions |
| 14090 | Examine why some compounds that have very little or no impact on human health must go through rigorous testing |
| 14091 | Eliminate internal roadblocks to ADAA, including the expanding levels of review and regulation, to meet the spirit of ADAA negotiation and legislative effort |
| 14100 | Be a resource for other federal agencies involved in combating non-tariff trade barriers |
| 15027 | Improve communication between the Office of Surveillance and Biometrics and the Office of Device Evaluation |
| 15034 | Adopt the National Committee for Clinical Laboratory Standards (NCCLS) anti-microbial susceptibility testing break points which reflect current emerging resistance patterns and extend these determinations to CDER as well |
| 15040 | Collaborate within HHS to bring FDA's approval of devices together with the Health Care Financing Administration (HCFA) payment for patient use of the device |
| 15045 | Consider having the device and drug manufacturers pool money to fund scientific investigations that are free from conflict of interest |
| 15051 | Mandate that every breast implant and all devices that have not been FDA approved include in the informed consent that the device is not formally approved because the manufacturer has not provided such evidence and that FDA is concerned about health problems |
| 15052 | Mandate that all chemicals and catalyst residues used in implantable devices be listed in the informed consent along with toxicity information |
| 15053 | Mandate that informed consent forms must be given to potential implant candidates at initial consultation along with the mandatory FDA breast implant information update |
| 15054 | Mandate a 7-day cooling-off period between initial breast implant visit and date of surgery to give patients adequate time to receive information by mail, including accurate percentages of complication rates and disease rates |
| 15055 | Design and implement a supplemental information checklist on frequent complications and diagnosis on devices suspected of having a long latency period for ease of reporting and collection of data for statistical analysis |
| 15056 | Mandate that all manufacturers halt marketing and require recalls when good manufacturing practices are violated and until they are corrected |
| 15059 | Review carefully any third-party evaluation products |
| 15061 | Clarify any non-payment decision by HCFA for patient use of a device |
| 15064 | Link each task that FDA performs specifically to the risks prevented by that function and determine a cost-benefit ratio |
| 15065 | Align Agency resources with statutory functions |
| 15067 | Hire good people, get rid of the ones that aren't so good |
| 15068 | Use more consultants |
| 15071 | Work synergistically with industry and others, including patient groups and professional societies to help meet statutory obligations |
| 15072 | Focus activities on high payoffs for public health |
| 15073 | Allow non-FDA organizations to do some of the initial work in developing some of the required FDAMA products and reserve for FDA the role of reviewing, critiquing and modifying |
| 15074 | Identify statutory responsibilities that are no longer necessary |
| 15077 | Prioritize what is being asked of FDA, which is too much, meaning that some things just aren't going to get done |
| 15079 | Mandate that accurate percentages of complication rates and disease rates be included on informed consent forms for silicon breast implants |
| 15080 | Submit an application fee to ensure the FDA has appropriate funds to conduct testing on the product submitted for the FDA approval to independent labs |
| 15081 | Enforce fines to help establish funds to ensure FDA can conduct testing on products submitted for FDA approval |
| 15082 | Restrict products that were grandfathered in, halt new sales, and allow only replacement devices |
| 15084 | Allow FDA to have the names of persons who have participated in studies of grandfather devices. |
FDA Plan for Statutory Compliance
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