FDA Postmarketing Requirements and Commitments Frequently Asked Questions

1. Purpose of Providing Information

The FDA provides this information under Section 130(a) of the Food and Drug Administration Modernization Act of 1997, which added section 506B to the Federal Food, Drug, and Cosmetic Act, requiring applicants to report annually on postmarketing requirements/commitments and for FDA to make certain information public. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

2. Content Included in the Section

The section includes non-proprietary information from FDA's internal database on postmarketing requirements/commitments, updated quarterly after verification. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

3. Source of Information

Information comes from Agency letters and annual status reports submitted by applicants, verified for accuracy before posting. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

4. Update Frequency

Information is updated in January, April, July, and October. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

5. Multiple Requirements or Commitments per Product

A product can have multiple requirements and/or commitments related to original NDA or BLA approvals and subsequent supplements. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

6. Annual Report Requirements for NDA and ANDA Applicants

Under 21 CFR 314.81, applicants must submit an annual report for every approved NDA and ANDA. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

7. Annual Report Requirements for BLA Applicants

Regulations require annual reports for BLA products for certain changes (21 CFR 601.12(d)), pediatric study summaries (21 CFR 601.28), and status reports on postmarketing requirements/commitments related to clinical aspects (21 CFR 601.70). Routine annual reports are not mandatory for licensed biological products. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

8. Submission Timing for Annual Status Reports

Applicants must submit annually within 60 days of the U.S. approval anniversary, continuing until all requirements/commitments are fulfilled or released. The due date is based on the original approval; separate reports are not required for supplements. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

9. New Reporting Requirements Under FDAAA

Section 505(o)(3)(E)(ii) requires periodic reporting on required studies/clinical trials, including those undertaken to investigate safety issues. Annual reports under section 506B and 21 CFR 314.81(b)(2)(vii) can satisfy this if including specified elements; failure to report is a violation. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

10. Timing for Information from Latest Annual Status Report to Appear

Updates may not appear in the same quarter due to verification delays; information changes quarterly based on the database. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

11. Searching the Database

Search by center (CDER/CBER), applicant, product, application number, status, required under, or approval date range. All fields optional; specific criteria narrow results. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

12. Search Results Display

Results show application/supplement info (applicant, product, number, approval date, report dates) and requirement/commitment details (number, required under, final report date, description, status, explanation). Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

13. Required Under: Accelerated Approval

Under 21 CFR 314.510 and 601.41, FDA approves based on surrogate endpoints, requiring post-approval confirmation of clinical benefit. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

14. Required Under: Animal Efficacy Rule

Under CFR 314.610(b)(1) and 601.91(b)(1), approvals based on animal data require postmarketing verification when feasible and ethical. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

15. Required Under: Pediatric Research Equity Act

PREA requires pediatric studies for certain applications, with waivers/deferrals possible; deferred studies are postmarketing requirements. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

16. Required Under: FDAAA Section 505(o)(3)

FDAAA authorizes required studies/clinical trials to assess or identify serious risks. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

17. Final Report Due Date Presence

Captured since April 2001; absence means information unavailable. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

18. Brackets in Commitment Text

Indicate redacted information under FOIA. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

19. Explanation of Status in Database

Brief progress explanation relative to schedule, displayed for pediatric (all) and others (delayed/terminated); unverified or missing explanations noted. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq

20. Requirement/Commitment Status Categories

• Pending: Not initiated past original start date.
• Ongoing: Progressing per schedule.
• Delayed: Progressing but behind schedule.
• Terminated: Stopped before completion.
• Submitted: Final report submitted, under review.
• Fulfilled: Final report satisfies requirement/commitment.
• Released: No longer required/committed. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-frequently-asked-questions-faq