About FDA
FDASIA-TRACK
FDA will communicate its progress towards accomplishing the requirements of the FDA Safety and Innovation Act by updating the chart below on a regular basis. Currently, the chart includes only those requirements with specific statutory dates set by Congress. Additional deliverables will be added to the chart over time as FDA continues to advance its implementation planning efforts.
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 | Statutory Date | FDA Lead Organization | Contact | Actions Completed |
|---|---|---|---|---|---|---|---|
| I | 103 | FR Notice | FDA shall determine the inflation and workload adjustments for PDUFA and publish them in the Federal Register. | 8/2/2012 | OFM | David.Miller@fda.hhs.gov | 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.Mills@fda.hhs.gov | |
| 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.Mills@fda.hhs.gov | |
| I | 103 | FR Notice | FDA shall establish fees for PFUFA and publish the fees and rationale for any adjustments in an FR notice. | 8/2/2012 | OFM | David.Miller@fda.hhs.gov | Completed 8/1/2012 |
| I | 104 | Report to Congress | FDA shall submit to Congress an annual Performance Report for PDUFA. | 1/28/2014 | OPL | User Fee Performance Reports | |
| II | 203 | FR Notice | FDA shall establish fees for MDUFA and publish the fees and rationale for any adjustments in an FR notice. | 8/2/2012 | OFM | David.Miller@fda.hhs.gov | Completed 7/31/2012 |
| II | 204 | Report to Congress | FDA shall submit to Congress an annual Performance Report for MDUFA. | 1/28/2014 | OPL | User Fee Performance Reports | |
| II | 204 | Public Report | FDA shall make MDUFA annual and quarterly performance data publicly available on the FDA website. | 3/1/2013 | CDRH | User Fee Performance Reports | |
| 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 User Fee Cover Sheet | Completed 10/25/2012 |
| 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 | Generic Drug User Fee Cover Sheet | 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 form (FDF) facilities and publish the fees in an FR notice. | 1/14/2013 | OFM | Generic Drug User Fee Cover Sheet | |
| 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 | Completed 10/2/2012 | |
| 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 | |
| III | 303 | Report to Congress | FDA shall submit to Congress an annual Fiscal Report for GDUFA. | 1/28/2014 | OFM | User Fee Performance Reports | |
| III | 303 | Report to Congress | FDA shall submit recommendations to Congress for generic drug user fee reauthorization. | 1/13/2017 | CDER | User Fee Performance Reports | |
| 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. | 8/1/2012 | OFM | Biosimilar User Fee Contacts | Completed 10/2/2012 |
| IV | 403 | Report to Congress | FDA shall submit to Congress an annual Performance Report for BSUFA. | 1/28/2014 | OPL | User Fee Performance Reports | |
| IV | 403 | Report to Congress | FDA shall submit to Congress an annual Fiscal Report for BSUFA. | 1/28/2014 | OFM | User Fee Performance Reports | |
| 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 | druginfo@fda.hhs.gov | |
| 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 final results of the study. | 9/30/2016 | CDER | druginfo@fda.hhs.gov | |
| IV | 403 | Report to Congress | FDA shall submit recommendations to Congress for biosimilar user fee program reauthorization. | 1/13/2017 | CDER | User Fee Performance Reports | |
| 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 | |
| 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@fda.hhs.gov | |
| 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. | 7/9/2013 | CDER | pdit@fda.hhs.gov | |
| V | 508 | Report to Congress | 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, and subsequent required reports, shall address a variety of specified topics including assessments of the timeliness and effectiveness of pediatric study planning, efforts to increase studies in newborns, and information on drugs for pediatric cancers. At least 180 days before the submission of each report, FDA shall consult with patient and other groups and obtain recommendations for the report. The reports must also be made publicly available on FDA's Internet website. | 7/8/2016 | OPT | Debbie Avant | |
| V | 510 | Public Meeting | FDA shall hold at least one public meeting to discuss ways to encourage/accelerate development of new therapies for pediatric rare diseases. | 1/9/2014 | OOPD | Gayatri.Rao@fda.hhs.gov | |
| 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. The report must describe key terms; discuss possible processes for industry to use to determine whether a new 510(k) premarket notification is required, and analyze how to use existing quality system requirements to reduce premarket burden, facilitate continual device improvement, and provide reasonable assurance of safety and effectiveness of modified devices. | 1/9/2014 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| 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. | 11/6/2012 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| VI | 614 | Proposed Rule | FDA must issue proposed Unique Device Identifier (UDI) regulations by December 31, 2012. | 12/31/2012 | CDRH | CDRH-FDASIA@fda.hhs.gov | Completed 7/12/2012 |
| 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. | 5/7/2013 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| 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 where production of such devices is limited to no more than 5 units per year of the device type. | 7/9/2014 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| 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. | 1/9/2014 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| VI | 620 | Proposed Rule | Not later than December 31, 2012, FDA shall issue a proposed rule implementing the requirement in section 515A(a)(2) of the FD&C Act that a person submitting an application for a Humanitarian Device Exemption under section 520(m) of the FD&C Act, or a premarket approval application (PMA) or supplement to a PMA submitted under section 515 of the FD&C Act, or a product development protocol under section 515 of the FD&C Act must include in the application or protocol, with respect to the device for which approval is sought and if readily available—(A) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (B) the number of affected pediatric patients. | 12/31/2012 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| VI | 620 | Final Rule | Not later than December 31, 2013, FDA shall issue a final rule implementing the requirement in section 515A(a)(2) of the FD&C Act that a person submitting an application for a Humanitarian Device Exemption under section 520(m) of the FD&C Act, or a premarket approval application (PMA) or supplement to a PMA submitted under section 515 of the FD&C Act, or a product development protocol under section 515 of the FD&C Act must include in the application or protocol, with respect to the device for which approval is sought and if readily available—(A) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (B) the number of affected pediatric patients. | 12/31/2013 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| 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, the number of registered establishments inspected by FDA, and the percentage of the FDA budget used to conduct these inspections. | 1/31/2014 | CDER | CDERCompliancePublic@fda.hhs.gov | |
| VII | 707 | Draft guidance | Not later than 1 year after the date of enactment, FDA shall issue guidance that describes the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection. | 7/9/2013 | ORA | FDASIAImplementationORA@fda.hhs.gov | |
| 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. | 7/9/2014 | ORA | FDASIAImplementationORA@fda.hhs.gov | |
| 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 | FDASIAImplementationORA@fda.hhs.gov | |
| 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. | 1/9/2014 | CDER | CDERCompliancePublic@fda.hhs.gov | |
| 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 promulgate regulations to establish good importer practices, and shall establish a system for registration of commercial importers. | 7/9/2015 | OP | Brian.Pendleton@fda.hhs.gov | |
| VIII | 801 | Final Rule | Not later than 2 years after the date of enactment, FDA shall adopt final regulations, following specified procedures, to implement the 5 years of market exclusivity awarded to drugs designated as qualified infectious disease products and include the list of qualifying pathogens. | 7/9/2014 | CDER | druginfo@fda.hhs.gov | |
| 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. | 7/7/2017 | CDER | druginfo@fda.hhs.gov | |
| VIII | 805 | Report to Congress | FDA shall submit a report to Congress on the designation, review, and approval of qualified infectious disease products and recommendations regarding qualifying pathogens and any additional programs or incentives that may be needed to promote the development of antibacterial drugs. | 7/7/2017 | HHS/CDER | druginfo@fda.hhs.gov | |
| 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 | druginfo@fda.hhs.gov | |
| 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. | 12/31/2014 | CDER | druginfo@fda.hhs.gov | |
| 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 | druginfo@fda.hhs.gov | |
| IX | 901 | Final Guidance | Not later than 1 year after the issuance of draft guidance (above), FDA shall issue final guidance on the clarified standard for accelerated approval and fast track processes, including issues for drugs for a rare disease or condition. | 7/9/2014 | CDER | druginfo@fda.hhs.gov | |
| 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 early evidence indicates the drug may offer substantial improvement over existing treatments. | 1/9/2014 | CDER | druginfo@fda.hhs.gov | |
| IX | 907 | Report to Congress | FDA shall issue a report describing the extent to which individuals in demographic subgroups, including sex, age, race, and ethnicity, participate in clinical trials. The report shall also address the extent to which safety and effectiveness data by demographic subgroups is included in premarket approval applications submitted to FDA. The report will be provided to Congress and posted on FDA’s Internet website. | 7/9/2013 | OWH | Pamela.Scott@fda.hhs.gov | |
| IX | 907 | Plan | The Commissioner 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. | 7/9/2014 | OMH | Jonca.Bull@fda.hhs.gov | |
| 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. | 1/9/2014 | CDER | Drug Shortages Information | |
| 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. | 1/31/2013 | CDER | Drug Shortages Information | |
| X | 1003 | Plan | FDA shall establish a task force to develop and implement a strategic plan for enhancing the agency's efforts to prevent and mitigate drug shortages. | 7/9/2013 | CDER | Drug Shortages Information | |
| X | 1003 | Report to Congress | Not later than one year after the date of enactment, FDA shall publish the drug shortage strategic plan and submit the report to Congress. | 7/9/2013 | CDER | Drug Shortages Information | |
| 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 | CDERCompliancePublic@fda.hhs.gov | |
| 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 | OC | megan.velez@fda.hhs.gov | |
| XI-C | 1122 | Other | To fight the significant rise in prescription drug abuse, FDA, in coordination with other federal agencies as appropriate, shall review federal initiatives and identify gaps and opportunities regarding the safe use of prescription drugs with potential for abuse and the treatment of prescription drug dependence. | 7/9/2013 | CDER/HHS | druginfo@fda.hhs.gov | |
| XI-C | 1122 | Public Report | Not later than one year after the date of enactment, the Secretary of Health and Human Services will post on the HHS Internet website a report on the findings of the review of federal initiatives, gaps, and opportunities regarding the safe use of prescription drugs with potential for abuse and the treatment of prescription drug dependence. | 7/9/2013 | CDER/HHS | druginfo@fda.hhs.gov | |
| 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 | druginfo@fda.hhs.gov | |
| XI-C | 1124 | 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 | darian.tarver@fda.hhs.gov | |
| 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). | 1/31/2014 | OPL | darian.tarver@fda.hhs.gov | |
| 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@fda.hhs.gov | |
| 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 | OC | Trang.Gisler@fda.hhs.gov | |
| XI-C | 1131 | 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 | darian.tarver@fda.hhs.gov | |
| 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). | 7/9/2013 | CDER | druginfo@fda.hhs.gov | |
| 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@fda.hhs.gov | |
| 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). | 9/7/2012 | CDER | CDEREXSEC@cder.fda.gov | |
| XI-C | 1141 | Report to Congress | Not later than one year after the date of enactment, FDA must submit a report to Congress on enhancing the interoperability of State prescription drug monitoring programs with other technologies used for detecting and reducing fraud, diversion, and abuse of prescription drugs. | 7/9/2013 | CDER/HHS | CDEREXSEC@cder.fda.gov | |
| 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. | 2/1/2013 | ACOMS | michael.ortwerth@fda.hhs.gov | |
| XI-C | 1142 | Public Report | Not later than 30 days after submitting the report on FDA advisory committees to Congress, FDA must make the report available to the public. | 3/1/2013 | ACOMS | michael.ortwerth@fda.hhs.gov | |
| II | 200 | Proposed Rule | By the end of FY 2013, FDA intends to issue a proposed rule exempting additional low risk medical devices from premarket notification | 9/30/2013 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| II | 200 | Final Rule | By the end of FY 2015, FDA intends to issue a final rule exempting additional low risk medical devices from premarket notification | 9/30/2015 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| II | 200 | Public Meeting | FDA will hold a minimum of two medical device Vendor Days each year. | 9/30/2013 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| II | 200 | Third party assessment | 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. | 3/31/2013 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| II | 200 | Third party assessment | For Phase 2 of the assessment, the contractor will evaluate the implementation of recommendations and publish a written assessment no later than February 1, 2016. | 2/1/2016 | CDRH | CDRH-FDASIA@fda.hhs.gov | |
| I | 100 | Public Report | "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." | 3/31/2015 | CDER | druginfo@fda.hhs.gov | |
| 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 | druginfo@fda.hhs.gov | |
| I | 100 | Public Report | "A final assessment of the new review program will be published by December 31, 2016, for public comment." | 12/31/2016 | CDER | druginfo@fda.hhs.gov | |
| I | 100 | Public Meeting | FDA will hold a public meeting by no later than March 30, 2017, during which public stakeholders may present their views on the success of the new review program, including improving the efficiency and effectiveness of the first cycle review process and decreasing the number of review cycles ultimately necessary for new drugs and biologics that are approved. | 3/30/2017 | CDER | druginfo@fda.hhs.gov | |
| 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. | 3/31/2015 | CDER | druginfo@fda.hhs.gov | |
| 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. | 9/30/2013 | CDER | druginfo@fda.hhs.gov | |
| 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. | 9/30/2015 | CDER | druginfo@fda.hhs.gov | |
| 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. | 9/30/2013 | CDER | druginfo@fda.hhs.gov | |
| 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. | 9/30/2014 | CDER | druginfo@fda.hhs.gov | |
| 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." | 3/31/2014 | CDER | druginfo@fda.hhs.gov | |
| I | 100 | Public Report | 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. 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. | 12/31/2013 | CDER | druginfo@fda.hhs.gov | |
| 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. | 9/30/2013 | CDER | druginfo@fda.hhs.gov | |
| 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. | 9/30/2013 | CDER | druginfo@fda.hhs.gov | |
| 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 workplan for project completion: pharmacy systems, prescriber education, providing benefit/risk information to patients, and practice settings. | 12/31/2013 | CDER | druginfo@fda.hhs.gov | |
| 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. | 9/30/2013 | CDER | druginfo@fda.hhs.gov | |
| 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." | 9/30/2014 | CDER | druginfo@fda.hhs.gov | |
| 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 | druginfo@fda.hhs.gov |
