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  1. Transparency

FDA-TRACK: FDASIA-TRACK

FDA-TRACK: FDASIA-TRACK

FDA will communicate its progress towards accomplishing the requirements of the FDA Safety and Innovation Act (FDASIA) by updating the chart below on a regular basis. After review of the requirements set forth in the law, the agency developed a comprehensive 3-year implementation plan, balancing high priority items with available resources to provide good faith estimates of completion dates for each item. Each task includes the targeted completion date and links to contacts and additional information.

Additional information about FDASIA can be found by going to the FDASIA Website. Also, additional information about the implementation of PDUFA V, MDUFA III, GDUFA, and BsUFA can be found at these FDA web sites. User Fee Commitment Letter deliverables are identified using the following Section numbers: PDUFA - 100; MDUFA - 200; GDUFA - 300; BSUFA - 400.

Title Section Deliverable Type Deliverable Description Target Date FDA Lead Organization Contact Actions Completed/Notes
I 100 Plan FDA will begin execution of the plan to implement the benefit-risk framework across review divisions in the pre and post-market human drug review process by the end of the fourth quarter of FY 2013, and the Agency will update the plan as needed and post all updates on the FDA website. 9/30/2013 CDER PDUFA V Information

Completed 9/30/2013

 

Implementation of this plan is in process

Enhancing Benefit-Risk Assessment in Regulatory Decision-Making

I 100 Final Guidance FDA shall periodically publish final guidance specifying the completed data standards, formats, and terminologies that sponsors must use to submit data in applications. 12/31/2014 CDER PDUFA V Information

Completed 12/17/2014

Final Guidance

I 100 FR Notice To address FDA-identified nonclinical data standards needs, FDA will request public input on the use of relevant already-existing data standards and the involvement of existing standards development organizations to develop new standards or refine existing standards. FDA will obtain this input via publication of a Federal Register notice that specifies a 60-day comment period. 3/30/2014 CDER PDUFA V Information

Therapeutic Areas Standards Initiative Project Plan –Version 1 published via FRN September 2013; Version 2 posted to the FDA website 7/1/2014;  Version 3 published October 2015

I 100 Plan FDA shall develop a project plan for distinct therapeutic indications, prioritizing clinical terminology standards development within and across review divisions. FDA shall publish a proposed project plan for stakeholder review and comment by June 30, 2013. FDA shall update and publish its project plan annually. 6/30/2013 CDER Priority Therapeutic Areas for Development

Report published on 10/23/2013

FR Notice published 10/30/2013 Open for public comment

FR Notice posted, Public Meeting held on 11/5/2012

Final Report

I 100 Final Guidance FDA will issue final guidance no later than 12 months from the close of the public comment period for the Draft eCTD Guidance on the standards and format of electronic submission of NDA, BLA and IND applications. 9/24/2015 CDER PDUFA V Information

Final Guidance published on 5/15/2015

 

Final Guidance on eCTD Technical Conformance Guide published October 2015

I 100 Draft Guidance To enhance the quality and efficiency of FDA's review of NDAs, BLAs, and INDs, FDA shall consult with stakeholders, including pharmaceutical manufacturers and other research sponsors, to issue draft guidance on the standards and format of electronic submission of applications by December 31, 2012. 12/31/2012 CDER  

Completed 1/3/2013

Draft Guidance

I 100 Self-assessment By the end of FY 2015, FDA will conduct (or fund by contract) an interim assessment to evaluate the strengths, limitations and the appropriate use of Sentinel for informing regulatory actions (e.g., labeling changes, PMRs and PMCs) to manage safety issues. 9/30/2015 CDER PDUFA V Information

Completed 9/24/2015

Interim Assessment

I 100 Public Meeting By the end of FY 2013, FDA will hold or support public meetings engaging stakeholders to discuss current and emerging Sentinel projects and facilitate stakeholder feedback and input regarding Sentinel projects that would be appropriate to meet the goals stated in the guidance. 1/31/2013 CDER PDUFA V Information

Completed 1/31/2013

Sentinel Initiative Public Workshop

I 100 Draft Guidance FDA will issue guidance by the end of FY 2014 on methodologies for assessing a Risk Evaluation and Mitigation Strategy. This guidance should specifically address methodologies for determining whether a specific Risk Evaluation and Mitigation Strategy with elements to assure safe use (ETASU) is: (i) commensurate with the specific serious risk listed in the labeling of the drug and (ii) considering the observed risk, not unduly burdensome on patient access to the drug. 6/30/2017 CDER PDUFA V Information

The REMS Evaluation Guidance has been drafted and is currently being reviewed by OCC.

I 100 Public Meeting By the end of FY 2013, FDA will initiate one or more public workshops on methodologies for assessing whether REMS are mitigating the risks they purport to mitigate and for assessing the effectiveness and impact of REMS, including methods for assessing the effect on patient access, individual practitioners, and the overall burden on the healthcare delivery system. 7/26/2013 CDER Public Meeting: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies
 

Completed 7/26/2013 

 

FDA held a 2-day public meeting to obtain input on issues and challenges associated with the standardization and assessment of risk evaluation and mitigation strategies (REMS) for drug and biological products. The docket for written comments will remain open indefinitely.  A link to the slide deck can be found here.

I 100 Public Report To move towards increased integration of REMS into the healthcare delivery system, FDA will issue a report of its findings by the first quarter of FY 2014 that will identify at least one priority project in each of the following areas including a work plan for project completion: pharmacy systems, prescriber education, providing benefit/risk information to patients, and practice settings. 9/30/2014 CDER PDUFA V Information

The REMS Standardization Report published on 9/24/2014

Public meeting was held in July 2013. FR Notice then published for stakeholder comment.

I 100 Public Meeting By the end of FY 2013, FDA will hold one or more public meetings to include the pharmaceutical industry, other government healthcare providers, patient groups, and partners from other sectors of the healthcare delivery system to explore strategies to standardize REMS, where appropriate, with the goal of reducing the burden of implementing REMS on practitioners, patients, and others in various healthcare settings. 7/26/2013 CDER Public Meeting: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies

Completed 7/25/2013

 

To obtain input from stakeholders about REMS standardization and evaluation, FDA held a public meeting to give stakeholders, including health care providers, prescribers, patients, pharmacists, distributors, drug manufacturers, vendors, researchers, standards development organizations, and the public an opportunity to provide input on ways to standardize and assess REMS. A link to the meeting transcript can be found here.

 

 

I 100 Draft Guidance By the end of FY 2013, FDA will develop and issue guidance on how to apply the statutory criteria to determine whether a Risk Evaluation and Mitigation Strategy is necessary  to ensure that the benefits of a drug outweigh the risks. 12/31/2016 CDER PDUFA V Information

Completed 09/21/2016

Draft Guidance

I 100 Public Meeting FDA will initiate a public process to nominate a set of disease areas that could benefit from a more systematic and expansive approach to obtaining the patient perspective on disease severity or unmet medical need. FDA will convene 4 meetings per year (CDER will host 17 meetings and CBER will host 3 meetings throughout PDUFA V). 9/24/2013 CDER Patient-Focused Drug Development: Disease Area Meetings Planned for Fiscal Years 2013-2015

This is an annual requirement. FY2013 was completed 09/24/2013. 

An FR notice announcing the diseases for FY 14-15 published 04/11/2013.

For FY 2013; the public process was begun with a FR Notice in September 2012 and public meeting was held on October 25, 2012; which proposed a set of disease areas and requested public comment on them through a docket.

The first 4 meetings were held on Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis, HIV, Lung Cancer, and Narcolepsy.

Meeting Website

I 100 Plan By the end of the first quarter of 2013, FDA will publish, for public comment, its draft plan to further develop and implement a structured benefit/risk assessment in the new drug approval process. 3/29/2013 CDER PDUFA V Information

Completed 3/5/2013

Draft Implementation Plan

I 100 Public Meeting By mid-FY 2014, FDA, through the Rare Disease Program, will conduct a public meeting to discuss complex issues in clinical trials for studying drugs for rare diseases, including such questions as endpoint selection, use of surrogate endpoints/Accelerated Approval, and clinical significance of primary endpoints; reasonable safety exposures; assessment of dose selection; and development of patient-reported outcome instruments. 1/6/2014 CDER PDUFA V Information The Public Workshop on Complex Issues in Rare Disease Drug Development was a 3-day meeting that was held January 6-8, 2014. The main goals were that FDA would foster discussion, hear diverse perspectives from experts, and for pediatric rare diseases (per statute), use the interactions to develop a strategic plan to encourage and accelerate development of pediatric rare disease therapies.
I 100 Public Meeting By the end of FY 2014, FDA will hold a public meeting to discuss FDA's qualification standards for drug development tools, new measurement theory, and implications for multi-national trials. 5/31/2015 CDER PDUFA V Information Meeting was held 4/1/2015
I 100 Public Meeting By the end of FY 2013, FDA will hold a public meeting to discuss the current status of biomarkers and pharmacogenomics and potential strategies to facilitate scientific exchanges in regulatory and non-regulatory contexts. 9/30/2014 CDER PDUFA V Information Meeting held on 9/5/2014
I 100 Draft Guidance Considering feedback and input received through a public meeting, FDA will publish draft guidance for comment describing FDA's intended approach to the use of meta-analyses in the FDA's regulatory review process by the end of FY 2015. 03/31/2017 CDER PDUFA V Information Guidance is complete and will begin clearance November 2016.
I 100 Public Meeting By the end of FY 2013, FDA will hold a public meeting engaging stakeholders in discussing current and emerging scientific approaches and methods for the conduct of meta-analyses, and to facilitate stakeholder feedback and input regarding the use of meta-analyses in the FDA's regulatory review process. 11/25/2013 CDER PDUFA V Information

Completed 11/25/2013

On November 25, 2013, FDA conducted a public meeting on Meta-Analyses of Randomized Controlled Clinical Trials for the Evaluation of Risk to Support Regulatory Decisions.

The input from the meeting will be used to develop a draft guidance that describes best practices for the conduct of meta-analyses and FDA's intended approach for the use of meta-analyses in regulatory decision-making. FDA is also publishing a white paper to facilitate discussion at the public meeting, which is avaliable online.

I 100 Draft Guidance By the end of the second quarter of FY 2015, FDA will publish draft guidance for review staff and industry describing best practices for communication between FDA and IND sponsors during drug development. 3/31/2016 CDER PDUFA V Information Guidance published 12/10/2015. The guidance is available here.
I 100 Public Meeting By June 30, 2015, FDA will hold a public meeting during which public stakeholders may present their views on the success of the new review program to date including: improving the efficiency and effectiveness of the first cycle review process; decreasing the number of review cycles ultimately necessary for new drugs and biologics that are approved; and helping to ensure that patients have timely access to safe, effective, and high quality new drugs and biologics. 6/30/2015 CDER PDUFA V Information  Meeting was held 5/202015.
I 100 Third Party Assessment An interim assessment of the new program for enhanced review transparency and communication for new molecular entity NDAs and original BLAs ("new review program") will be published by March 31, 2015, for public comment. 3/30/2015 CDER PDUFA V Information

Completed 3/31/2015

Interim Assessment

I 100 FR Notice The new review program for new molecular entity NDAs and original BLAs shall be evaluated by an independent contractor with expertise in assessing the quality and efficiency of biopharmaceutical development and regulatory review programs. The statement of work for this effort will be published for public comment prior to beginning the assessment. The assessments will occur continuously throughout the course of the new review program. 7/9/2012 CDER  

Statement of Work published in July 2012

I 103 FR Notice FDA shall determine the inflation and workload adjustments for PDUFA and publish them in the Federal Register. 8/3/2012 OFM David Miller

Completed 8/1/2012

I 103 Public Report FDA shall contract with an independent accounting or consulting firm to periodically review the adequacy of the workload adjustment for PDUFA and publish the results of those reviews for public comment. The first review, due at the end of FY 2013, is to examine the performance of the adjustment since fiscal year 2009. 9/30/2013 OPL Giles Miles

Completed 5/6/2013

Report

I 103 FR Notice FDA shall establish fees for PFUFA and publish the fees and rationale for any adjustments in an FR notice. 8/3/2012 OFM David Miller

Completed 8/1/2012

I 103 Public Report FDA shall contract with an independent accounting or consulting firm to periodically review the adequacy of the PDUFA workload adjustment and publish the results of those reviews for public comment. The second review, due at the end of FY 2015, is to examine the continued performance of the adjustment. 9/30/2015 OPL Giles Miles

 Completed 5/6/2015

 Evaluation of the PDUFA Workload Adjuster 2009-2013

I 104 Report to Congress FDA shall submit to Congress an annual Performance Report for PDUFA. 1/28/2014 OPL PDUFA Performance Reports

Completed 1/31/2014

2013 PDUFA Performance Report

II 200 FR Notice FDA will update its website to reflect the following: 1. A list of prioritized device guidance documents (an "A-list") that the Agency intends to publish within 12 months of the date this list is published each fiscal year; and 2. A list of device guidance documents (a "B-list") that the Agency intends to publish, as the Agency's guidance-development resources permit each fiscal year. 1/1/2013 CDRH CDRH-FDASIA

Completed 1/1/2013

II 200 Draft Guidance FDA will update the interactive review guidance to enhance the interactive review process between FDA and applicants to facilitate timely completion of premarket reviews based on accurate and complete information. 3/5/2013 CDRH CDRH-FDASIA

Completed 3/5/2013

II 200 Final Guidance FDA will update the interactive review guidance to enhance the interactive review process between FDA and applicants to facilitate timely completion of premarket reviews based on accurate and complete information. 9/30/2015 CDRH CDRH-FDASIA

Completed 4/4/2014

Final Guidance

II 200 Final Guidance FDA will publish final guidance outlining electronic copy of device submissions (e-Copy). 1/1/2013 CDRH CDRH-FDASIA

Completed 12/31/2012

Final Guidance

II 200 Draft Guidance FDA will publish draft guidance outlining electronic copy of device submissions (e-Copy). 10/1/2012 CDRH CDRH-FDASIA

Completed 10/17/2012

Draft Guidance

II 200 Final Guidance FDA will issue final guidance on a structured process for managing Pre-Submissions (draft guidance issued on 7/13/12). 2/4/2014 CDRH CDRH-FDASIA

Completed 2/18/2014

Final Guidance

II 200 Draft Guidance FDA will issue guidance regarding the review and management expectations for Clinical Laboratory Improvement Amendments waivers applications throughout the entire submission process. 3/31/2014 CDRH CDRH-FDASIA

Completed 3/12/2014

Final Guidance

II 200 Final Guidance FDA will solicit public comments on the Good Review Management Practices (GRMP) draft guidance document and then finalize the guidance document. 9/30/2017 CDRH CDRH-FDASIA  
II 200 Draft Guidance FDA will incorporate the results of the independent assessment of the review process for device submissions into a Good Review Management Practices (GRMP) draft guidance document. 2/1/2017 CDRH CDRH-FDASIA  
II 200 Plan FDA will publish an implementation plan within 6 months of receipt of the final recommendations from the independent assessment. 12/11/2014 CDRH CDRH-FDASIA

Completed 12/11/2013

II 200 Plan FDA will publish an implementation plan based on the independent assessment's set of high-priority recommendations from the independent assessment within 6 months of receipt. 6/11/2014 CDRH CDRH-FDASIA

Completed 6/11/2014

II 200 Third Party Assessment The final comprehensive findings and recommendations from the independent assessment will be published within 1 year of contract award. 6/11/2014 CDRH CDRH-FDASIA

Completed 6/11/2014

Final Assessment completed 2/1/2016

II 200 Third Party Assessment Findings on high-priority recommendations from the independent assessment will be published within six months of awarding the contract. 9/30/2013 CDRH CDRH-FDASIA MDUFA II/III Evaluation-Priority Recommendations
II 200 Other FDA and the device industry will participate in a comprehensive two-phase assessment of the process for the review of device applications. For Phase 1, no later than the end of the second quarter of FY 2013, FDA will contract with a private, independent consulting firm capable of performing the technical analysis, management assessment, and program evaluation tasks required to address the assessment scope. 5/30/2013 CDRH CDRH-FDASIA

Completed

II 200 Other FDA will hold a minimum of two medical device Vendor Days each year. 9/30/2013 CDRH CDRH-FDASIA

This is an annual requirement. FY2013 was completed 8/22/2013.

II 200 Final Guidance FDA will issue guidance providing objective criteria for making decisions to accept or refuse to accept premarket approval applications for review. 1/1/2013 CDRH CDRH-FDASIA

Completed 12/31/2012

Final Guidance

II 200 Final Guidance FDA will issue guidance providing objective criteria for making decisions to accept or refuse to accept 510(k) premarket notifications for review. 1/1/2013 CDRH CDRH-FDASIA

Completed 12/31/2012

Final Guidance

II 200 Final Guidance By the end of FY 2015, FDA intends to issue a final guidance exempting additional low risk medical devices from premarket notification. 9/30/2015 CDRH CDRH-FDASIA

Completed 8/14/2015

Final Guidance

II 200 Draft Guidance By the end of FY 2013, FDA intends to develop a draft list of low risk medical devices that will be considered for exemption from premarket notification. 8/1/2014 CDRH CDRH-FDASIA

Completed 8/1/2014

Final Guidance

II 203 FR Notice FDA shall establish fees for MDUFA and publish the fees and rationale for any adjustments in an FR notice. 8/3/2012 OFM David Miller

Completed 7/31/2012

FR Notice

II 204 Report to Congress FDA shall submit to Congress an annual Performance Report for MDUFA. 1/28/2014 OPL MDUFA Performance Reports

Completed 1/31/2014

2013 MDUFA Performance Report

II 204 Public Report FDA shall make MDUFA quarterly performance data publicly available on the FDA website. 3/1/2013 CDRH MDUFA Performance Reports

Completed 2/12/2013

III 300 Other FDA will develop new and/or enhance existing facility databases (API and FDF manufacturing and clinical/ bioequivalence site) to be populated by industry. These databases will, at a minimum, contain information for generics-related firms, including addresses and Data Universal Numbering System (DUNS) numbers, and will link facilities to DMFs and ANDAs and will contain other information as necessary. 9/30/2013 CDER

GDUFA Information

 

Completed 2/28/2013
III 300 Public Report FDA will make inspection classification results and date of the last facility inspection available to the public and industry on FDA's website on timely basis. 10/1/2012 CDER

GDUFA Information

 

Inspection Classification Database Search
III 302 FR Notice FDA will publish in the Federal Register the one-time backlog fee for abbreviated new drug applications (ANDAs) that are pending on October 1, 2012, and that have not received a tentative approval prior to that date. (GDUFA Fee). 10/31/2012 OFM Generic Drug Backlog Fee Information

Completed 10/25/2012

FR Notice

III 302 FR Notice FDA shall establish fees for GDUFA (drug master file fees and filing fees) and publish the fees in an FR notice. 10/31/2012 OFM FR Notice announcing DMF user fees for FY13

Completed 10/25/2012

FR Notice

III 302 FR Notice FDA will establish generic drug user fee rates (GDUFA) for domestic and foreign active pharmaceutical ingredient (API) and finished dosage format (FDF) facilities and publish the fees in an FR notice. 1/15/2013 OFM FR Notice announcing API and FDF user fees for FY13

Completed 1/17/2013

FR Notice

III 302 FR Notice FDA will publish in the Federal Register a notice requiring each person that owns certain specified facilities or organizations to submit to FDA information on the identity of each such facility, site, or organization. The facilities and organizations specified are those that: produce one or more finished dosage forms of a human generic drug or an active pharmaceutical ingredient (API) contained in a human generic drug, or a site or organization in which a bioanalytical study is conducted, a clinical research organization, a contract analytical testing site, or a contract repackager site. 10/1/2012 CDER

GDUFA Information

 

Completed 10/2/2012

FR Notice

III 302 Website FDA shall make available on its Web site a list of DMF numbers for DMFs that have undergone an initial completeness assessment and are available for reference. -- CDER

GDUFA Information

 

DMF List
III 303 Report to Congress FDA shall submit to Congress an annual Performance Report for all generic drug applications, amendments and prior approval supplements, that includes the number of applications that met the GDUFA goals, the average total time to decision, including the number of calendar days spent during FDA review and calendar days spent by sponsor; total number of applications that were pending for more than 10 months on July 9, 2012, and the number of pending applications on which FDA took final regulatory action in the previous fiscal year. 1/28/2014 OPL User Fee Performance Reports

Completed 1/31/2014

2013 GDUFA Performance Report

III 303 Report to Congress FDA shall submit to Congress an annual Fiscal Report for GDUFA. 1/28/2014 OFM Generic Drug User Fee Financial Reports

Completed 4/30/2014

2013 GDUFA Financial Report

III 303 FR Notice Prior to beginning negotiations with the generic industry concerning extension of generic drug user fees beyond Fiscal Year 2017, FDA shall consult with stakeholders. 4/1/2015 CDER

GDUFA Information

 

FR Notice posted on 6/3/2015
IV 402 FR Notice FDA shall establish Initial Biosimilar Biological Product Development Fee, Annual Biosimilar Biological Product Development Fee, Reactivation Fee, Biosimilar Biological Product Application Fee, Establishment Fee, and Product Fee and publish fees in an FR notice. 8/1/2012 OFM  BsUFA Contacts

Completed 8/1/2012

IV 403 Third Party Assessment FDA shall contract with independent accounting or consulting firm to study the workload volume and full costs associated with the process for review of biosimilar biological product applications, and publish, for public comment, interim results of the study. 6/1/2015 CDER Drug Info at fda.gov

Completed on 9/24/2015

Interim Report

IV 403 Report to Congress FDA shall submit to Congress and annual Fiscal Report for BSUFA. 1/28/2014 OFM Biosimilar User Fee Financial Reports

Completed 4/30/2014

FY2013 BsuFA Financial Report

IV 403 Report to Congress FDA shall submit to Congress an annual Performance Report for BSUFA. 1/28/2014 OPL User Fee Performance Reports

Completed 1/31/2014

2013 BsUFA Performance Report

IV 403 Report to Congress FDA shall submit recommendations to Congress for biosimilar user fee program reauthorization. 1/13/2017 CDER  

Completed 12/22/2016 

BsUFA Performance Report 

IV 408 Report to Congress FDA shall submit to Congress an annual report that includes the number of biosimilar applications filed; the percentage of filed biosimilar applications that were approved and an explanation of how FDA is managing the biosimilar review program to ensure that PDUFA funds are not being used to support the review of biosimilar applications. 1/28/2015 OPL User Fee Performance Reports

Completed 1/28/2015

2014 BsUFA Performance Report

V 503 SOP / New Template FDA shall issue internal standard operating procedures for any significant modifications to initial pediatric study plans, agreed initial pediatric study plans, and written requests. Such operating procedures shall be posted to FDA's website. 7/9/2013 CDER PDIT

Completed 6/25/2013

Presentation presented to Industry outlining how to apply the new pediatric laws to current drug development including the recent modifications to initial pediatric study plans

Outline of procedures and timelines for review of PSPs and Written Requests by the Pediatric Review Committee

V 506 Draft Guidance Not later than 1 year after enactment, FDA shall issue guidance to implement requirements relating to the submission of plans to study drugs in children. 7/9/2013 CDER PDIT

Completed 7/15/2013

FDA is announcing the availability of a draft guidance for industry entitled ‘‘Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.’’

 

Draft Guidance

V 506 Proposed Rule Not later than 1 year after enactment, FDA shall promulgate proposed regulations to implement requirements relating to the submission of plans to study drugs in children. 11/30/2017 CDER PDIT The rule is undergoing editing and clearance at FDA and the expected completion date is November 2017.
V 508 FR Notice At least 180 days before submission of the report to Congress, FDA shall consult with stakeholders to obtain recommendations including suggestions for modifications that would improve pediatric drug research and labeling. 1/9/2016 OPT PDIT Completed 2/26/2015
V 508 Report to Congress Not later than 4 years after enactment, FDA shall submit a report to Congress discussing the implementation of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act which generally provide for the improved study of drugs in children. The report shall include assessments of the timeliness and effectiveness of pediatric study planning, efforts to increase studies in newborns, and information on drugs for pediatric cancers. The reports must also be made publicly available on FDA's Internet website. 7/8/2016 OPT PDIT Completed 6/29/2016 and can be found here
 
V 510 Public Meeting Not later than 18 months after enactment, FDA shall hold at least one public meeting to discuss ways to encourage/accelerate development of new therapies for pediatric rare diseases. 1/8/2014 OOPD Public Workshop – Complex Issues in Developing Drug and Biological Products for Rare Diseases

Completed 1/8/2014

Meeting held January 6-8, 2014 as a 3-day public workshop on Complex issues in Rare Disease Drug Development. Links to additional information can be found here.

V 510 Public Report Not later than 180 days after the public meeting, FDA shall issue a report that includes a strategic plan for encouraging/accelerating development of new therapies for pediatric rare diseases. 7/7/2014 OOPD Gayatri Rao

Completed 7/7/2014

Developing Products for Rare Diseases & Conditions

VI 601 Draft Guidance FDA intends to revise and re-issue the draft guidance, entitled, "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations." This guidance, when final, will, among other things, provide FDA's interpretation of and policy on section 601 of FDASIA, which states that FDA may not disapprove an IDE because, among other reasons, the investigation may not support a device clearance or approval or a different investigation may be necessary to support clearance or approval. 6/14/2013 CDRH CDRH-FDASIA

Completed 6/14/2013

Draft Guidance

VI 603 Final Guidance FDA intends to issue a final appeals guidance, which will include, among other things, information regarding the requirements under section 603 of FDASIA for a request for a supervisory review of a significant decision. 5/17/2013 CDRH CDRH-FDASIA

Completed 5/17/2013

Final Guidance

VI 603 Draft Guidance FDA intends to issue a Q&A draft appeals guidance to provide proposed interpretation of key provisions of section 603 of FDASIA, including, among othes, what constitutes a "significant decision." When finalized, FDA intends to include the questions and answers in the draft guidance as an appendix to the appeals guidance. 5/30/2013 CDRH CDRH-FDASIA

Completed 5/17/2013

Draft Guidance

VI 604 Other FDA shall withdraw the draft guidance entitled, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” (July 27, 2011). 7/17/2012 CDRH CDRH-FDASIA

Completed 7/17/2012; Guidance Withdrawn

VI 604 Report to Congress FDA shall submit a report to Congress regarding when a 510(k) premarket notification should be submitted for modifications or changes to a legally marketed device. 1/9/2014 CDRH CDRH-FDASIA

Completed 2/25/2014

Report to Congress

VI 607 Other In lieu of submitting a report under section 510(k) and submitting a [de novo] request for classification under clause (i) for a device, if a person determines there is no legally marketed device upon which to base a determination of substantial equivalence ... a person may submit a [de novo] request under this clause for the FDA to classify the device.   CDRH CDRH-FDASIA FDA is using its authority under this new provision to review 'direct' de novo petitions from sponsors (i.e., de novo petitions for devices for which the sponsor did not first submit a 510(k) and receive an NSE decision from FDA).
VI 608 Other Section 608 of FDASIA changed the process for reclassifying devices and requiring premarket approval for preamendment devices from rulemaking to an administrative order process, which includes publication of a proposed order in the Federal Register, consideration of comments, and panel meeting before issuing a final order.   CDRH CDRH-FDASIA FDA is using its authority under this new provision to reclassify devices and call for PMAs by administrative order.
VI 611 FR Notice FDA shall establish and publish in the Federal Register criteria to reaccredit or deny reaccreditation of third-party reviewers (called "Accredited Persons"). Any reaccreditation must specify the particular activities and the devices, for which such persons are accredited to review. 2/15/2013 CDRH CDRH-FDASIA

Completed 2/15/2013

Guidance

VI 613 Draft Guidance FDA intends to issue guidance that includes an interpretation of section 613 of FDASIA, which, among other things, expands the types of devices approved under a humanitarian device exemption that can be sold for profit. Such devices now include devices intended for treatment or diagnosis of a disease/condition that does not occur in pediatric patients or that occurs in pediatric patients in such numbers that the development of the device for such patients is "impossible, highly impracticable, or unsafe." This guidance, when final, will supersede the guidance entitled "Humanitarian Device Exemption (HDE) Regulation: Questions and Answers," issued July 8, 2010. 3/31/2014 CDRH CDRH-FDASIA

Completed 3/18/2014

VI 614 Final Rule FDA must issue final Unique Device Identifier (UDI) regulations not later than 6 months after the close of the comment period for the proposed rule. FDA shall implement these final UDI regulations for devices that are implantable, life-saving, and life-sustaining, not later than 2 years after regulations are finalized. 6/19/2013 CDRH CDRH-FDASIA

Completed 9/24/2013

FR Notice

VI 614 Proposed Rule FDA must issue proposed Unique Device Identifier (UDI) regulations by December 31, 2012. 7/10/2012 CDRH CDRH-FDASIA

Completed

Proposed Rule 7/10/2012

Amendment to Proposed Rule 11/19/2012

Final Rule 9/24/2013

VI 617 Draft Guidance Not later than 2 years after the date of enactment, FDA shall issue final guidance on replication of custom devices used to treat rare conditions such that no other device is domestically available to treat, where conducting a clinical investigation on such device would be impractical, and production of such devices is limited to no more than 5 units per year of the device type. 1/31/2014 CDRH CDRH-FDASIA

Completed 1/14/2014

VI 617 Final Guidance Not later than 2 years after the date of enactment, FDA shall issue final guidance on replication of custom devices used to treat rare conditions such that no other device is domestically available to treat, where conducting a clinical investigation on such device would be impractical, and production of such devices is limited to no more than 5 units per year of the device type. 12/31/2014 CDRH CDRH-FDASIA

Completed 9/24/2014

Final Guidance

VI 618 Public Report FDA, in consultation with the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), shall post on the FDA, ONC, and FCC websites, a report containing a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication. 3/31/2014 CDRH CDRH-FDASIA

Completed 4/3/2014

FDASIA Health IT Report

VI 620 Proposed Rule Not later than December 31, 2012, FDA shall issue a proposed rule that requires submitters to FDA of premarket approval applications (PMAs), supplements to PMAs, humanitarian device exemption applications (HDEs), and product development protocols (PDPs) for devices to include, if readily available, information about pediatric subpopulations that suffer from a disease or condition that the device is intended to treat, diagnose, or cure. 2/19/2013 CDRH CDRH-FDASIA

Completed 2/19/2013

VI 620 Final Rule Not later than December 31, 2013, FDA shall issue a final rule that requires submitters to FDA of premarket approval applications (PMAs), supplements to PMAs, humanitarian device exemption applications (HDEs), and product development protocols (PDPs) for devices to include, if readily available, information about pediatric subpopulations that suffer from a disease or condition that the device is intended to treat, diagnose, or cure. 12/31/2013 CDRH CDRH-FDASIA

Completed 1/10/2014

FR Notice

VI 620 Draft Guidance Not later than December 31, 2012, FDA shall issue a proposed rule that requires submitters to FDA of premarket approval applications (PMAs), supplements to PMAs, humanitarian device exemption applications (HDEs), and product development protocols (PDPs) for devices to include, if readily available, information about pediatric subpopulations that suffer from a disease or condition that the device is intended to treat, diagnose, or cure. FDA intends to issue a companion guidance to this rule. 3/31/2014 CDRH CDRH-FDASIA

Completed 2/19/2013

VI 620 Final Guidance Not later than December 31, 2012, FDA shall issue a proposed rule that requires submitters to FDA of premarket approval applications (PMAs), supplements to PMAs, humanitarian device exemption applications (HDEs), and product development protocols (PDPs) for devices to include, if readily available, information about pediatric subpopulations that suffer from a disease or condition that the device is intended to treat, diagnose, or cure. FDA intends to issue a companion guidance to this rule. 3/31/2014 CDRH CDRH-FDASIA

Completed 5/1/ 2014

Final Guidance

VII 701, 702 Draft Guidance FDA shall specify the unique facility identifier (UFI) system to be used for domestic and foreign drug establishment registrations. 9/5/2013 CDER CDER Compliance

Completed 9/5/2013

Draft Guidance

VII 701, 702 Final Guidance FDA shall specify the unique facility identifier (UFI) system to be used for domestic and foreign drug establishment registrations. 4/9/2015 CDER CDER Compliance

Completed 11/5/2014

Final Guidance

VII 705 Public Report Starting in 2014, the FDA will publish by February 1 of each year a website report on the number of establishments registered with FDA and inspected by FDA, and the percentage of the FDA budget used to conduct these inspections. 1/31/2014 CDER CDER Compliance

Completed 1/31/2014

2013 Annual Report on Inspections of Establishments

VII 707 Draft Guidance Not later than 1 year after the date of enactment, FDA shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection. 7/15/2013 ORA ORA FDASIA Implementation

Completed 7/15/2013

Draft Guidance

VII 707 Final Guidance Not later than 1 year after the date of enactment, FDA shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection. 12/22/2014 ORA ORA FDASIA Implementation

Completed 10/21/2014

Final Guidance

VII 708 Proposed Rule Not later than 2 years after the date of enactment, FDA shall issue regulations providing for notice and an opportunity to appear and introduce testimony prior to administrative destruction of a refused admission drug valued under $2,500. 4/18/2014 ORA ORA FDASIA Implementation

Completed 5/6/2014

Proposed Rule

VII 708 Final Rule Not later than 2 years after the date of enactment, FDA shall issue regulations providing for notice and an opportunity to appear and introduce testimony prior to administrative destruction of a refused admission drug valued at $2,500 or less. 9/30/2015 ORA ORA FDASIA Implementation

Completed 9/15/2015

Final Rule

VII 709 FR Notice Before issuing regulations to implement administrative detention authority with respect to drugs, FDA shall consult with stakeholders, including drug manufacturers. 4/9/2013 ORA ORA FDASIA Implementation

Completed 4/28/2013

VII 709 Proposed Rule Not later than 2 years after date of enactment and after consulting with stakeholders including drug manufacturers, FDA shall issue regulations to implement administrative detention authority with respect to drugs. 7/15/2013 ORA ORA FDASIA Implementation

Completed 7/15/2013

Proposed Rule

VII 709 Final Rule Not later than 2 years after the date of enactment and after consulting with stakeholders including manufacturers of drugs, FDA shall promulgate regulations to implement administrative detention authority with respect to drugs. 7/9/2014 ORA ORA FDASIA Implementation

Completed 5/29/2014

Final Rule

VII 711 Proposed Rule FDA may revise regulations to implement Section 711 and other Sections of Title VII. 9/30/2017 CDER CDER Compliance  
VII 711 Final Rule FDA may revise regulations to implement Section 711 and other Sections of Title VII. 12/31/2018 CDER CDER Compliance  
VII 713 Proposed Rule

Not later than 18 months after the date of enactment, FDA shall adopt final regulations which may require importers to submit certain electronic information as acondition of import.

9/30/2017 CDER CDER Compliance  
VII 713 Final Rule Not later than 18 months after the date of enactment, FDA shall adopt final regulations which may require importers to submit certain electronic information as a condition of import. 12/31/2018 CDER CDER Compliance  
VII 714 Proposed Rule Not later than 36 months after date of enactment, FDA, in consultation with the Secretary of Homeland Security acting through Customs and Border Protection, shall issue regulations to establish good importer practices for drugs. 9/30/2017 OP Brian Pendleton  
VII 714 Final Rule Not later than 36 months after date of enactment, FDA, in consultation with the Secretary of Homeland Security acting through Customs and Border Protection, shall issue regulations to establish good importer practices for drugs. 12/31/2018 OP Brian Pendleton  
VII 714 Proposed Rule Not later than 36 months after date of enactment, FDA, in consultation with the Secretary of Homeland Security acting through Customs and Border Protection, shall issue regulations to require registration of commercial importers of drugs. 9/30/2017 OP Brian Pendleton  
VII 714 Final Rule Not later than 36 months after the date of enactment, FDA, in consultation with the Secretary of Homeland Security acting through Customs and Border Protection, shall issue regulations to require registration of commercial importers of drugs. 12/31/2018 OP Brian Pendleton  
VIII 801 Final Rule Not later than 2 years after the date of enactment, FDA shall adopt final regulations, following specified procedures, to implement this section, including establishing a list of qualifying pathogens. 7/7/2014 CDER Drug Info at fda.gov

Completed 6/5/2014

FR Notice

VIII 801 Proposed Rule Not later than 2 years after the date of enactment, FDA shall adopt final regulations, following specified procedures, to implement this section, including establishing a list of qualifying pathogens. 8/19/2013 CDER Drug Info at fda.gov

FR Notice released 6/5/2013.  Public comment period ends on 8/12/2013.

FDA has published a proposed rule implementing a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). The proposed rule establishes a proposed list of “qualifying pathogens” that have the potential to pose a serious threat to public health, and describes the methodology for creating and maintaining the list. Establishing this list is related to FDA’s efforts to encourage the development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections. It is a very important public health issue and one that FDA is working with academia and industry to address.
 

VIII 801 List At least every 5 years FDA shall review, modify, and publish the list of qualifying pathogens and issue a regulation revising the list as needed. FDA shall consult with CDC and others when establishing the list; also make the methodology for developing the list publicly available. 7/7/2014 CDER Drug Info at fda.gov

6/5/2013: Proposed Rule for 801 contains the proposed list, open for public comment until 8/12/2013

Consulted with CDC and NIH via public meeting (Part 15 Hearing)

VIII 804 Other FDA shall review and, if needed, revise no fewer than 3 guidance documents per year regarding the conduct of clinical trials for antibacterial and antifungal drugs. 7/9/2013 CDER Drug Info at fda.gov

1. Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Final published 09/28/2012 (conversion of draft guidance to final) Final Guidance

2. Acute Bacterial Otitis Media: Final published 10/01/2012 (conversion of draft guidance to final) Final Guidance

3. Acute Bacterial Sinusitis: Final published 10/05/2012 (conversion of draft guidance to final) Final Guidance

VIII 806 Draft Guidance Not later than June 30, 2013, FDA shall publish draft guidance that addresses how data may be used for the efficient and streamlined development of antibacterial drugs to treat serious or life-threatening bacterial infections, including approaches for developing limited-spectrum antibacterials. 6/28/2013 CDER Drug Info at fda.gov

Completed 7/1/2013

Draft Guidance

FDA Webinar presented on new Draft Guidance for industry on 9/27/2013

VIII 806 Final Guidance Not later than December 31, 2014, FDA shall publish final guidance, after notice and opportunity for public comment, that addresses how data may be used for the efficient and streamlined development of antibacterial drugs to treat serious or life-threatening bacterial infections.   CDER Drug Info at fda.gov Completed August 2017
IX 901 Draft Guidance Not later than 1 year after the date of enactment, FDA shall issue draft guidance on the clarified standard for accelerated approval and fast track processes, including issues for drugs for a rare disease or condition. 7/9/2013 CDER Drug Info at fda.gov

Completed 6/25/2013

Draft Guidance

IX 901 Final Guidance Not later than 1 year after the issuance of draft guidance, FDA shall issue final guidance on the clarified standard for accelerated approval and fast track processes, including issues for a rare disease or condition. 7/9/2014 CDER Drug Info at fda.gov

Completed 5/30/2014

Final Guidance

IX 902 Draft Guidance Not later than 18 months after the date of enactment, FDA shall issue draft guidance implementing the requirements on breakthrough therapies to treat a serious or life-threatening condition where preliminary clinical evidence shows the drug may offer substantial improvement over existing treatments. 1/9/2014 CDER Drug Info at fda.gov

Completed 6/26/2013

Draft Guidance

FR Notice

IX 902 Final Guidance Not later than 1 year after the close of the comment period for the draft guidance, FDA shall issue final guidance on implementing the requirements with respect to breakthrough therapies to treat a serious or life-threatening condition where preliminary clinical evidence shows the drug may offer substantial improvement over existing treatments. 7/9/2014 CDER Drug Info at fda.gov

Completed 5/30/2014

Final Guidance 

IX 907 Public Report Not later than 1 year after enactment, FDA will issue a report that describes the participation of demographic subgroups (sex, age, race, and ethnicity) in clinical studies submitted to FDA in marketing applications. The report will also describe the inclusion of safety and effectiveness data for demographic subgroups in marketing applications submitted to FDA. The report will be posted on FDA’s website and provided to Congress. 7/9/2013 OWH FDASIASECTION 907 Information

Completed 8/20/2013

FDA Report

IX 907 Plan Not later than 1 year after providing the report to Congress, FDA shall publish an action plan on the FDA website with recommendations on improving the completeness and quality of data analyses on demographic subgroups, including such data in labeling, and making such data available to patients and providers. 8/20/2014 OMH Jonca Bull

Completed 8/20/2014

Action Plan

X 1001 Proposed Rule Not later than 18 months after the date of enactment, FDA shall adopt final regulations implementing provisions regarding drug shortages, including defining certain terms. 10/23/2013 CDER Drug Shortages Information FDA has the proposed rule, Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Productsissued. If finalized, the rule will expand the requirement for drug and biologic manufacturers to notify FDA early about issues that could lead to a potential shortage. The FR Notice published on 11/04/2013.
X 1001 Final Rule Not later than 18 months after the date of enactment, FDA shall adopt final regulations implementing provisions regarding drug shortages, including defining certain terms. 1/9/2015 CDER Drug Shortages Information

Final Rule published 7/8/2015.

FR Notice

X 1002 Report to Congress FDA shall submit an annual report to Congress providing information on drug shortages, including information on the agency's efforts to prevent or mitigate shortages. 12/31/2013 CDER Drug Shortages Information

Completed 2/6/2014

Drug Shortages Report to Congress

X 1003 Other FDA shall identify or establish a mechanism by which health care providers and other third-party organizations may report to FDA evidence of a drug shortage. 12/18/2013 CDER Drug Shortages Information

Completed 1/11/2013

Report Drug Shortages

X 1003 Strategic Plan FDA shall establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages. 7/9/2013 CDER Drug Shortages Information

Completed 10/31/2013

Drug Shortage Strategic Plan

XI-B 1112 Report to Congress Not later than 18 months after the date of enactment, FDA shall determine whether any changes to FDA drug regulations are necessary for medical gases. FDA will obtain input from medical gas manufacturers and other interested members of the public about whether changes are needed. The agency will submit a report to Congress regarding any changes to the regulations. 1/9/2014 CDER CDER Compliance

Created a certification program for designated medical gases (1111) Comments on Certification (FDASIA Section 1111) Docket Establishment

 

Report to Congress Completed

 

Guidance Completed June 2017

XI-C 1121 Draft Guidance Not later than 2 years after the date of enactment, FDA shall issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA. 7/9/2014 CDER Drug Info at fda.gov

Completed 6/17/2014

Draft Guidance

XI-C 1122 Draft Guidance Not later than 6 months after the date of enactment, FDA shall promulgate guidance on the development of abuse-deterrent drug products. 1/9/2013 CDER Drug Info at fda.gov

Completed 1/9/2013

Draft Guidance

XI-C 1124 Strategic Plan Not later than 1 year after the date of enactment, FDA shall develop a strategy and implementation plan for advancing regulatory science for medical products in order to promote the public health and advance innovation in regulatory decision-making. The plan developed must be consistent with the goals established in the user fee negotiations for drugs and biologics (PDUFA), devices (MDUFA), generic drugs (GDUFA), and biosimilars BSUFA). 7/9/2013 OPL Malcolm Bertoni

Completed 7/8/2013

Strategic Plan

XI-C 1124 Report to Congress For fiscal years 2014 through 2016, FDA shall include information on the progress made in advancing regulatory science in the annual performance reports on the implementation of the user fee programs for drugs and biologics (PDUFA), devices (MDUFA), generic drugs (GDUFA), and biosimilars BSUFA). 1/31/2015 OPL User Fee Performance Reports

Completed 7/8/2013

XI-C 1125 Report to Congress Not later than 1 year after the date of enactment, FDA shall submit a report to Congress on the milestones and a completion date for developing and implementing a comprehensive information technology strategic plan; a comprehensive inventory of FDA's information technology systems, how FDA uses the strategic plan to guide the agency's modernization projects; and the extent to which FDA is implementing information technology recommendations of the Government Accountability Office. 7/9/2013 OO (OIM) Carolyn Yancey Completed 11/4/2013
XI-C 1128 Report to Congress Not later than one year after the date of enactment, FDA shall submit a report to Congress on the agency's small business assistance activities, including information on all of FDA's small business assistance offices, partnership efforts between FDA and the Small Business Administration, outreach efforts to small businesses, and other specified topics. 7/9/2013 OP Catherine Lorraine

Completed 7/9/2013

Small Business Report to Congress

XI-C 1131 Strategic Plan Not later than one year after enactment, FDA will submit a report to Congress on a strategic management plan for CDER, CBER, and CDRH which will include goals and priorities for improving efficiency, actions that will develop the workforce at all the centers, and the mechanisms that will be used to measure progress in achieving the goals of the plan. 7/9/2013 OPL Patricia Stewart

Completed 7/9/2013

Strategic Plan

XI-C 1132 Draft Guidance Not later than 1 year after the date of enactment, FDA shall issue guidance describing the types of modifications to approved Risk Evaluation and Mitigation Strategies that shall be considered to be minor modifications of such strategies for the purposes of section 505-1(h)(2)(A). 12/15/2014 CDER Drug Info at fda.gov

Completed 4/7/2015

Draft Guidance

XI-C 1138 Plan Not later than one year after the date of enactment, FDA must issue a communication plan to inform and educate health care providers and patients, with a particular focus on underrepresented subpopulations, on the benefits and risks of medical products. FDA must seek public comment on the communication plan and post it on the agency's Internet website. 7/9/2013 OMH, OPA Jonca Bull

Completed 7/9/2013

Communication Plan

Docket for public comment on plan opened 7/11/2013

XI-C 1139 Public Meeting Not later than 60 days after the date of enactment (if practicable) FDA must hold a public meeting to ask for advice and recommendations to help make scheduling recommendations to the Drug Enforcement Administration regarding drugs that contain hydrocodone, either combined with other pain medicines (analgesics) or used as a cough medicine (antitussive). 10/29/2012 CDER CDER EXESEC

Advisory Committee Meeting held on 1/24/13-1/25/13.

This meeting was rescheduled to January 2013 due to the postponement of the October 29-30, 2012, because of the unanticipated weather conditions caused by Hurricane Sandy.

XI-C 1142 Report to Congress Not later than February 1 of each year, FDA shall submit a report to Congress describing specific information on FDA advisory committees including such things as the number of people nominated to the committees, the number who are nominated and willing to serve, the number of vacancies on committees, and the number of people contacted to serve on a committee who did not because of the potential for their participation to constitute a disqualifying financial interest under federal law. 2/1/2014 ACOMS Michael Ortwerth

Completed 2/3/2014

Report to Congress

XI-C 1142 Draft Guidance FDA shall issue guidance describing how it reviews financial interests that do not meet the statutory definition of a disqualifying interest under section 208 of Title 18, United States Code for the purposes of participating in a particular matter. 12/31/2015 ACOMS Michael Ortwerth

Completed 6/29/2016

Draft Guidance

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