FDA develops guidance to provide its policy perspectives and recommendations on a wide variety of topics. The guidance documents below may be of special interest to existing or prospective medical countermeasure (MCM) sponsors, and other stakeholders, including state, tribal, local and territorial public health preparedness personnel.
Other Information of Interest (press releases, notices, etc.)
- January 2017: Guidance - Emergency Use Authorization of Medical Products and Related Authorities - This guidance finalizes the draft guidance, Emergency Use Authorization of Medical Products and Related Authorities (April 2016) and replaces the following two guidance documents: Emergency Use Authorization of Medical Products (July 2007) and Emergency Use Authorization Questions and Answers (April 2009). (Federal Register notice)
November 2016: Draft guidance for industry - Submission of Quality Metrics Data (PDF, 340 KB) - to help develop compliance and inspection policies and practices, improve the Agency’s ability to predict, and therefore possibly mitigate, future drug shortages, and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing, FDA intends to initiate a quality metrics reporting program. The revised draft gudiance describes FDA's plans for an initial, voluntary phase of this program. Comment by January 24, 2017. (Federal Register notice)
November 2016: Guidance for industry - Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF, 123 KB) - describes FDA's current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements (Federal Register notice)
November 2016: FDA is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. To ensure that the Agency considers your comments in this review, submit comments by January 9, 2017. Also see the Pharmaceutical Users Software Exchange (PhUSE) SDSP template (PDF, 74 KB)
August 2016: The HHS Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and FDA are announcing the availability of a draft guidance: Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs (PDF, 163 KB). This draft guidance is intended to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for the IRB. The draft guidance provides an IRB Written Procedures Checklist that incorporates the FDA and HHS regulatory requirements for IRB written procedures and additional topics that FDA and OHRP recommend including in IRB written procedures. Submit comments by October 3, 2016. (Federal Register notice)
- July 2016: Draft Guidance - Principles for Co-development of an In Vitro Companion Diagnostic Device With a Therapeutic Product; Draft Guidance for Industry and Food and Drug Administration Staff; Availability (Federal Register notice) - comment by October 13, 2016
- May 2016: Draft Guidance - Use of Electronic Health Record Data in Clinical Investigations (PDF, 247 KB) - The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations - comment by July 18, 2016 (Federal Register notice)
- May 2016: Draft Guidance - Special Protocol Assessment (PDF, 640 KB) - SPA is a process in which sponsors may request to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal trials to determine if they adequately address scientific and regulatory requirements. This draft guidance revises the guidance for industry Special Protocol Assessment issued in May 2002. After it has been finalized, this guidance will replace the May 2002 guidance. Significant changes from the 2002 version include: clarifying which protocols are eligible for SPA; adding animal rule efficacy protocols intended to support approval under 21 CFR part 314, subpart I, and 21 CFR part 601, subpart H, for drugs and biological products, respectively; adding protocols intended to support approval of a biosimilar biological product; providing greater detail about the content of an SPA submission; and clarifying the process for rescinding an SPA agreement.
- March 2016: Draft Guidance - Labeling for Biosimilar Products (PDF, 143 KB) - comment by June 3, 2016 (Federal Register notice) - comment period extended to August 2, 2016 (Federal Register notice June 6, 2016) - see also: From our perspective: Biosimilar product labeling
- December 2015: Draft Guidance - Safety Assessment for Investigational New Drug Application Safety Reporting (PDF, 411 KB) - comment by February 16, 2016 (Federal Register notice)
December 2015: Draft Guidance - Best Practices for Communication Between IND Sponsors and FDA During Drug Development (PDF, 253 KB) (Federal Register notice) - comment by February 8, 2016
November 2015: Guidance for industry - Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (PDF, 306 KB) (Federal Register notice)
October 2015: Final Guidance - Product Development Under the Animal Rule (PDF, 563 KB)
October 2015: Draft Guidance for Industry - Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF, 113 KB) - comment by December 21, 2015 (Federal Register notice)
- August 2015: Draft guidance - Rare Diseases: Common Issues in Drug Development (PDF, 306 KB) (Federal Register notice)
July 2015: Draft Guidance for Industry - Request for Quality Metrics (PDF, 250 KB) and August 24, 2015 Quality Metrics Public Meeting - The public meeting and draft guidance are intended to gain stakeholders’ perspective in various aspects of the development and planned implementation of a quality metrics program launched under the authority of section 704 of the Food, Drug, and Cosmetic Act (FD&C Act). The guidance includes an explanation of CDER and CBER approaches to collecting and using data to aid in ensuring that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science and that they support continuous improvement and innovation in the pharmaceutical manufacturing industry. Register by August 7, 2015. Read an FDA Voice blog post about Quality Metrics. Submit comments on the draft guidance by November 27, 2015 (date extended). (Federal Register notice, correction of docket number)
July 2015: Guidance for Industry - Analytical Procedures and Methods Validation for Drugs and Biologics (PDF, 134 KB) (Federal Register notice)
July 2015: Final Guidance - Meetings with the Office of Orphan Products Development (PDF, 94 KB) - This guidance provides recommendations to industry, researchers, patient groups, and other stakeholders interested in requesting a meeting with FDA's Office of Orphan Products Development (OOPD) on issues related to orphan drug designation requests, humanitarian use device (HUD) designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related topics of concern. (Federal Register notice)
May 2015: FDA is delaying the compliance date for the final rule for the electronic submission of postmarketing safety reports for human drugs and biological products that published in the Federal Register of June 10, 2014. The compliance date for the final rule published at 79 FR 33072 is delayed until September 8, 2015.
May 2015: Draft Guidance for Industry - Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators (PDF, 431 KB) (Federal Register notice)
April 2015: Guidance for Industry - Risk Evaluation and Mitigation Strategies Modifications and Revisions (PDF, 635 KB) - This guidance provides information on how FDA will define and process submissions for modifications and revisions to risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS. (Federal Register notice)
March 2015: Draft Guidance for Industry - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (PDF, 336 KB) (Federal Register notice)
March 2015: Draft Guidance for Industry - Use of Electronic Informed Consent in Clinical Investigations - Questions and Answers (PDF, 110 KB) (Federal Register notice)
February 2015: Draft Guidance for Industry - Individual Patient Expanded Access Applications: Form FDA 392 (PDF, 473 KB) - Related: read a blog post about how this new form will help FDA streamline expanded access to investigational drugs; learn more about expanded access (compassionate use), including information for patients, physicians and industry
January 2015: Draft Guidance for Industry Current Good Manufacturing Practice Requirements for Combination Products - more about combination products
December 2014: Draft Guidance for Industry - General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (PDF, 375 KB) (Federal Register notice)
December 2014: Guidance for Industry - Drug Supply Chain Security Act (DSCSA) Implementation--Product Tracing Requirements (PDF, 56 KB) - This guidance provides information pertaining to statutory requirements that will take effect on January 1, 2015, regarding the provisions to provide and capture product tracing information under section 582(b)(1), (c)(1), and (e)(1) of the FD&C Act. More about the DSCSA. (Federal Register notice)
December 2014: Guidance for Industry - Providing Regulatory Submissions in Electronic Format--Standardized Study Data (PDF, 124 KB) - CDER and CBER
December 2014: Guidance for Industry - Providing Regulatory Submissions in Electronic Format--Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (PDF, 81 KB) - CDER and CBER
May 2014: Product Development Under the Animal Rule (PDF, 2MB) (Draft) This revised draft guidance replaces the 2009 draft guidance for industry entitled “Animal Models--Essential Elements to Address Efficacy Under the Animal Rule” and addresses a broader scope of issues for products developed under the Animal Rule. (Federal Register notice )
April 2014: Meetings with the FDA Office of Orphan Products Development (PDF, 92K) (Draft) (Federal Register notice )
March 2014: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (PDF, 169 KB) (Draft) (Federal Register notice )
December 2013: Guidance for Industry - Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
June 2013: Expedited Programs for Serious Conditions--Drugs and Biologics (PDF, 252 KB) (Draft)
February 2012: Postmarket Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (PDF, 218 KB) - FDA response to comments on this guidance (January 6, 2015)
October 2010: Qualification Process for Drug Development Tools (PDF, 190 KB) (Draft)
February 2000: Formal Meetings with Sponsors and Applicants for PDUFA Products (PDF, 30 KB)
Indication-Specific Guidances (Drugs)
Search all guidances (Drugs)
August 2016: Final Guidance - Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (PDF, 423 KB)
- April 2016: Draft Guidance - Data Integrity and Compliance With CGMP (PDF, 120 KB) - comment by June 14, 2016 (Federal Register notice)
February 2016: FDA is announcing the availability of a draft guidance for industry Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax (PDF, 565 KB). The purpose of this draft guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This draft guidance supersedes the draft guidance entitled “Inhalational Anthrax (Post-Exposure)—Developing Antimicrobial Drugs” issued in March 2002. Comment by April 18, 2016. (Federal Register notice)
December 2015: Draft Guidance - Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base (PDF, 63 KB) - This guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing technology. Comment by February 22, 2016. (Federal Register notice)
October 2015: Guidance for Industry - Acceptability of Draft Labeling to Support ANDA Approval (generic drugs)
April 2011: Influenza: Developing Drugs for Treatment and/or Prophylaxis (PDF, 417 KB)
November 2007: Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (PDF, 242 KB) (Draft)
March 2006: Internal Radioactive Contamination - Development of Decorporation Agents (PDF, 177 KB)
March 2004: Potassium Iodide Shelf Life Extension; Guidance for Federal Agencies and State and Local Governments (PDF, 156 KB)
March 2004: Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF, 139 KB) (Draft)
January 2003: Prussian Blue Drug Products — Submitting a New Drug Application (PDF, 159 KB)
- December 2002: KI in Radiation Emergencies - Questions and Answers (PDF, 161 KB)
- December 2001: Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (PDF, 40 KB)
Calcium-DTPA and Zinc-DTPA, FDA encourages manufacturers to submit new drug applications (NDAs) for this product.
Vaccines, Gene Therapies, and Cell Therapies (Biologics)
Search all guidances (Biologics)
- January 2017: Guidance - Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus (PDF, 99 KB) - notifies blood establishments that FDA has determined Ebola virus to be a transfusion-transmitted infection (TTI) and provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor eligibility, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission is declared in at least one country. The guidance document applies to Ebola virus (species Zaire ebolavirus). The recommendations apply to routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015. (Federal Register notice)
July 2016: Guidance - Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (PDF, 174 KB) (Federal Register notice)
- March 2016: Guidance for Industry - Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (PDF, 392 KB) (Federal Register notice)
October 2015: Draft Guidance for Industry - Manufacturing Site Change Supplements: Content and Submission (PDF, 684 KB) (CDRH and CBER) (Federal Register notice)
August 2015: Draft Guidance for Industry - Nonproprietary Naming of Biological Products (PDF, 111 KB, Federal Register notice) and proposed rule: Designation of Official Names and Proper Names for Certain Biological Products - submit comments on the draft guidance by October 27, 2015 and the proposed rule by November 12, 2015. Related links: FDA Biosimilars page - FDA Voice: Naming and Biological Products
August 2015: Guidance for Industry - Providing Submissions in Electronic Format--Postmarketing Safety Reports for Vaccines (PDF, 77 KB) (Federal Register notice)
June 2015: Final Guidance for Industry - Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products (PDF, 313 KB) (Federal Register notice)
May 2015: Final Rule - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use - To better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture.
- November 2013: Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products
February 2010: Characterization and Qualification of Cell Substrates and other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases (PDF, 406 KB)
September 2007: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms (PDF, 184 KB)
November 2007: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (PDF, 88 KB)
Diagnostics, Medical Devices and Personal Protective Equipment (PPE)
Device advice: comprehensive regulatory assistance (from CDRH), including How to Market Your Device
Expedited Access Pathway Program - a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA) or are eligible for de novo requests
January 2017: FDA is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation. This order is effective February 13, 2017.
December 2016: Guidance - Postmarket Management of Cybersecurity in Medical Devices (PDF, 1.2 MB) (Federal Register notice) - FDA will host a webinar about this guidance on January 12, 2017 - also see FDA Voice: Managing Medical Device Cybersecurity in the Postmarket: At the Crossroads of Cyber-safety and Advancing Technology
October 2016: Draft Guidance - Software as a Medical Device (SaMD): Clinical Evaluation (PDF, 801 KB) - this draft guidance was prepared under the auspices of the International Medical Device Regulators Forum (IMDRF). It pertains to the conduct of clinical evaluation of SaMD and focuses on the general principles of clinical evaluation, which includes establishing the scientific validity, clinical performance, and analytical validity for a SaMD. The draft guidance is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the risk of the SaMD. Comment by December 13, 2016. (Federal Register notice)
August 2016: FDA issued draft updated recommendations (PDF, 1.6 MB) to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market (Federal Register notice), including a separate guidance (PDF, 784 KB) applicable to software devices (Federal Register notice). Submit comments by November 7, 2016. On August 25, 2016, FDA will host a webinar about these draft guidances. Read the news release
July 2016: Draft Guidance - Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (PDF, 499 KB) (Federal Register notice) - On September 23, 2016 FDA will hold a workshop to obtain feedback on two FDA draft guidances, Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases and Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics that describes new approaches to regulate NGS-based tests. Also see: FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests and Precision Medicine
June 2016: Final Guidance - Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices (PDF, 696 KB) - On August 8, 2016, FDA will host a webinar on this guidance, which provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric patients in pre-market approval applications (PMAs), humanitarian device exemptions (HDEs) and de novo requests. It also facilitates continued efforts to address unmet medical device needs for pediatric patients.
- May 2016: Draft Guidance - Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers (PDF, 1.4 MB) - (Federal Register notice) - comment by September 12, 2016 (comment deadline extended)
- May 2016: Draft Guidance - Technical Considerations for Additive Manufactured Devices (PDF, 548 KB) - This draft guidance provides FDA's initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3D printing. Comment by August 8, 2016.
- April 2016: Final Guidance - Radiation Biodosimetry Medical Countermeasure Devices (PDF, 514 KB) (Federal Register notice)
December 2015: Final Guidance - Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings (PDF, 319 KB) (Federal Register notice) - read more about medical gowns
November 2015: FDA is re-proposing to classify in vitro diagnostic devices for Bacillus species (including B. anthracis) detection into class II (special controls) after considering, among other information, the recommendations of the Microbiology Devices Advisory Panel. FDA is re-proposing to establish special controls in a draft special controls guideline that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the devices. In addition, FDA is re-proposing to restrict use and distribution of the devices. Submit comments on the proposed rule by February 16, 2016.
October 2015: Draft Guidance for Industry - Manufacturing Site Change Supplements: Content and Submission (PDF, 684 KB)(CDRH and CBER) (Federal Register notice)
- May 2015: FDA is extending the comment period for the Radiation Biodosimetry Devices (Draft Guidance) (PDF, 379 KB) published in the Federal Register of December 30, 2014. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. Comments are now due June 29, 2015. December 2014: FDA has developed this draft guidance to facilitate study designs to establish the analytical and clinical performance characteristics of radiation biodosimetry medical countermeasure devices. Radiation biodosimetry countermeasure devices are devices used for the purpose of reconstructing the ionizing radiation dose received by individuals or populations using physiological, chemical or biological markers of exposure found in humans. (Federal Register notice)
May 2015: Draft Guidance for Industry and FDA Staff - Adaptive Designs for Medical Device Clinical Studies (PDF, 563 KB) (Federal Register notice)
May 2015: Draft Guidance for Industry - Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices (PDF, 1.4 MB)
April 2015: Guidance for Industry - Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval (PDF, 500 KB)
April 2015: Guidance for Industry - Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (PDF, 683 KB)
- November 4, 2014: CDRH Industry Basics Workshop - view presentations from this webinar, including IDE Basics, 510(k), De Novo program, CAPA basics, and medical device reporting (21 CFR Part 803)
October 2014: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Federal Register notice ) (press release) - October 29, 2014 webinar on this guidance: recorded webinar (video/audio), printable slides (PDF, 227 KB), transcript (PDF, 256 KB)
August 2014: Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices (PDF, 799 KB)
August 2014: FDA Decisions for Investigational Device Exemption Clinical Investigations (PDF, 631 KB)
August 2014: Unique Device Identification System: Small Entity Compliance Guide (PDF, 518 KB); Unique Device Identifier System: Frequently Asked Questions, Vol. 1 (PDF, 726 KB); more information on Unique Device Identification (UDI)
July 2014: FDA launched a new learning tool for academic institutions and science and technology innovators called the National Medical Device Curriculum, to advance understanding of FDA's medical device regulatory processes.
May 2014: FDA is proposing the reclassification of antigen based rapid influenza detection test (RIDT) systems intended to detect influenza virus antigen directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation. More information is available in the Federal Register notice .
April 2014: Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (Draft); FDA news release about this draft guidance
November 2013: Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff - Presentation on this guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (PDF, 270 KB)
- November 2011: In Vitro Diagnostic Devices for Yersinia spp. Detection Class II Special Controls Guidance Document (PDF, 173 KB) (Draft)
June 21, 2016: Final Guidance - Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices (PDF, 696 KB) - On August 8, 2016, FDA will host a webinar on this guidance, which provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric patients in pre-market approval applications (PMAs), humanitarian device exemptions (HDEs) and de novo requests. It also facilitates continued efforts to address unmet medical device needs for pediatric patients.
- March 2016: Draft Guidance for Industry - Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans (PDF, 408 KB) (Federal Register notice)
- May 2015: Draft guidance - Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices (PDF, 1.1 MB)
- December 2014: Draft guidance - General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (PDF, 375 KB)
- November 2014: Draft guidance - Rare Pediatric Disease Priority Review Vouchers
- May 2014: Providing Information about Pediatric Uses of Medical Devices
- March 2014: Premarket Assessment of Pediatric Medical Devices
Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Records and Reports
Study data standards resources, including Study Data Technical Conformance Guide v2.0 (December 17, 2014)
December 9, 2016: Guidance - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF, 146 KB) - The guidance is intended to aid certain trading partners in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. This guidance includes a new section, for comment purposes only, that describes when manufacturers should notify FDA of a high risk that a product is illegitimate. Submit comments on this draft section by February 7, 2017. (Federal Register notice)
On November 9-10, 2016, FDA will hold a public hearing - Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (Silver Spring, MD and webcast) - the purpose of this public hearing is to obtain comments on FDA's regulation of firms' communications about medical products, with a particular focus on firms' communications about unapproved uses of their approved/cleared medical products - to attend or present at the public hearing, register by October 19, 2016 - comments will be accepted until January 9, 2017
September 2016: Draft guidance - FDA's Application of Statutory Factors in Determining When a REMS Is Necessary (PDF, 129 KB) - This draft guidance is intended to clarify how FDA applies the factors set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. Comment by November 21, 2016. (Federal Register notice)
September 2016: Draft guidance - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (PDF, 435 KB) - This draft guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. Comment by November 21, 2016. (Federal Register notice)
September 2016: FDA is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (such as academic researchers, regulated industries, consortia, and patient groups) on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and New Biological Therapeutics from October 2007 to December 2015. Comments received on this list will help FDA determine the utility of the list and may assist FDA in developing databases on biomarkers for drug development in the future. Comment by November 18, 2016.
- August 2016: FDA is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. As part of proposed changes to this rule, FDA seeks comment on the impact of expanding part 58 to include covered Animal Rule studies, and what other changes to the regulations, beyond amending the scope and definitions, are needed to address issues unique to covered Animal Rule studies. The comment period has been extended; comment by January 21, 2017.
August 2016: Notice of Proposed Rulemaking, from CDC - CDC is amending its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments are being proposed to aid public health responses to outbreaks of communicable diseases such as the largest recorded outbreak of Ebola virus disease (Ebola) in history, the recent outbreak of Middle East Respiratory Syndrome (MERS) in South Korea, and repeated outbreaks and responses to measles in the United States, as well as the ongoing threat of other new or re-emerging communicable diseases. Comment by October 14, 2016.
June 2016: Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form (Form FDA 3926, PDF, 88 KB) - also see Expanded Access to Investigational Drugs for Treatment Use Q&A (PDF, 180 KB) and Charging for Investigational Drugs Under an IND Q&A (PDF, 87 KB) - more about Expanded Access
February 2016: Guidance for Industry - Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act-Compliance Policy (PDF, 85 KB), effective February 29, 2016 (Federal Register notice)
December 2015: Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. FDA is announcing an opportunity for public comment on the proposed collection of certain information from product sponsors, manufacturers and public health authorities under the guidance "Emergency Use Authorization of Medical Products." The guidance describes the Agency's general recommendations and procedures for issuance of Emergency Use Authorizations (EUAs) under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 2004 (Pub. L. 108-276). Comment on this proposed information collection by February 22, 2016.
November 2015: Drug Supply Chain Security Act (DCSA) Implementation: Product Tracing Requirements for Dispensers—Compliance Policy (PDF, 58 KB) - Update: compliance deadline extended to March 1, 2016 (Federal Register notice)
- September 2015: Proposed Rule - Federal Policy for the Protection of Human Subjects - The departments and agencies listed in this Federal Register notice propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The comment period has been extended; comments now close January 6, 2016.
November 2014: FDA has developed Drug Trials Snapshots to provide information to the public about who participated in the clinical trials for new FDA-approved drugs. Drug Trials Snapshot is part of a pilot project to provide information about the sex, age, race and ethnicity of clinical participants for a small group of recently approved drugs. (Federal Register notice)
- June 2014: Final rule - list of qualifying pathogens under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods.
FDA has determined that the following pathogens comprise the list of “qualifying pathogens:” Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Helicobacter pylori, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. For more information, view the Federal Register notice
Related: statement from Janet Woodcock, MD on examining ways to combat Antibiotic Resistance and Foster New Drug Development (June 14, 2016)
- June 2013: FDA Safety and Innovation Act presentation (PDF, 791 KB), including information on the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safetey and Innnovation Act (FDASIA), and Qualified Infectious Disease Product (QIDP) designation (see Title VIII - GAIN, starting on slide 8)
Amendments to Sterility Test Requirements for Biological Products (21 CFR 600.3(q), 21 CFR 610.12, 21 CFR 680.3) (2012)
Regulatory Pathways Supporting Development and Approval of Vaccines Formulated with Novel Adjuvants, presentation at the Vaccine Forum, Washington, D.C., January 2012
Revision of the Requirements for Live Vaccine Processing (21 CFR 600.11) (2007)