Guidance on Annual Status Reports of Postmarketing Studies
FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.
FDA published guidance on Oct. 20, 2020 for applicants required to annually report the status of postmarketing studies and clinical trials concerning a product’s clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology as postmarketing requirements (PMRs) or postmarketing commitments (PMCs) under section 506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 Code of Federal Regulations (CFR) 314.81(b)(2)(vii) and 601.70.
The guidance explains when and how to submitFDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and Form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics. The guidance stresses that these forms do not replace existing requirements to submit other FDA forms and “are not intended to accompany or replace any submissions related to postmarketing studies or clinical trials that are not subject to the reporting requirements of section 506B of the FD&C Act.”
“The guidance does not apply to voluntary studies or clinical trials conducted by an applicant or on an applicant’s behalf that are neither required nor agreed upon in writing. This guidance also does not apply to PMCs related to chemistry, manufacturing, and controls or stability studies,” the guidance states.
Source: FDA
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
