Notice2024-08649
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
Primary source
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Published
April 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants are required to, or have agreed to, conduct is on the FDA's website entitled "Postmarketing Requirements and Commitments: Reports" (https:// www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post- marketingPhaseIVCommitments/ucm064436.htm).
Full Text
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<title>Federal Register, Volume 89 Issue 79 (Tuesday, April 23, 2024)</title>
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[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Notices]
[Pages 30380-30381]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-08649]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0946]
Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the Agency's annual report entitled ``Report on the
Performance of Drug and Biologics Firms in Conducting Postmarketing
Requirements and Commitments.'' Under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), FDA is required to report annually on the
status of postmarketing requirements (PMRs) and postmarketing
commitments (PMCs) required of, or agreed upon by, application holders
of approved drug and biological products. The report on the status of
the studies and clinical trials that applicants are required to, or
have agreed to, conduct is on the FDA's website entitled
``Postmarketing Requirements and Commitments: Reports'' (<a href="https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm">https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm</a>).
[[Page 30381]]
FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5367, Silver Spring, MD 20993-0002, 301-796-0700; or
James Myers, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
Section 506B(c) of the FD&C Act (21 U.S.C. 356b(c)) requires FDA to
publish an annual report on the status of postmarketing studies that
applicants are required to, or have committed to, conduct and for which
annual status reports have been submitted. Under Sec. Sec.
314.81(b)(2)(vii) and 601.70 (21 CFR 314.81(b)(2)(vii) and 601.70),
applicants of approved drug products and licensed biological products
are required to submit annually a report on the status of each clinical
safety, clinical efficacy, clinical pharmacology, and nonclinical
toxicology study or clinical trial either required by FDA (PMRs) or
that they have committed to conduct (PMCs), either at the time of
approval or after approval of their new drug application, abbreviated
new drug application, or biologics license application, as applicable.
The status of PMCs concerning chemistry, manufacturing, and production
controls and the status of other studies or clinical trials conducted
on an applicant's own initiative are not required to be reported under
Sec. Sec. 314.81(b)(2)(vii) and 601.70 and are not addressed in this
report. Furthermore, section 505(o)(3)(E) of the FD&C Act (21 U.S.C.
355(o)(3)(E)) requires that applicants report periodically on the
status of each required study or clinical trial and each study or
clinical trial ``otherwise undertaken . . . to investigate a safety
issue . . .''
An applicant must report on the progress of the PMR/PMC on the
anniversary of the drug product's approval \1\ until the PMR/PMC is
completed or terminated and FDA determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either no longer feasible or would no
longer provide useful information.
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\1\ An applicant must submit an annual status report on the
progress of each open PMR/PMC within 60 days of the anniversary date
of U.S. approval of the original application or on an alternate
reporting date that was granted by FDA in writing. Some applicants
have requested and been granted by FDA alternate annual reporting
dates to facilitate harmonized reporting across multiple
applications.
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II. Fiscal Year 2022 Report
With this notice, FDA is announcing the availability of the
Agency's annual report entitled ``Report on the Performance of Drug and
Biologics Firms in Conducting Postmarketing Requirements and
Commitments.'' Information in this report covers any PMR/PMC that was
established, in writing, at the time of approval or after approval of
an application or a supplement to an application and summarizes the
status of PMRs/PMCs in fiscal year 2022 (i.e., as of September 30,
2022). Information summarized in the report reflects combined data from
the Center for Drug Evaluation and Research and the Center for
Biologics Evaluation and Research and includes the following: (1) the
number of applicants with open PMRs/PMCs; (2) the number of open PMRs/
PMCs; (3) the timeliness of applicant submission of the annual status
reports (ASRs); (4) FDA-verified status of open PMRs/PMCs reported in
Sec. 314.81(b)(2)(vii) or Sec. 601.70 ASRs; (5) the status of closed
PMRs/PMCs; and (6) the distribution of the status by fiscal year (FY)
of establishment \2\ (FY2016 to FY2022) for PMRs and PMCs open at the
end of FY2022, or those closed within FY2022. Additional information
about PMRs/PMCs is provided on FDA's website at <a href="https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.html">https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.html</a>.
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\2\ The establishment date is the date of the formal FDA
communication to the applicant that included the final FDA-required
(PMR) or requested (PMC) postmarketing study or clinical trial.
Dated: April 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08649 Filed 4-22-24; 8:45 am]
BILLING CODE 4164-01-P
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