💊FDA Report on Drug Firms' Postmarketing Requirements and Commitments
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
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 FDA's website entitled "Postmarketing Requirements and Commitments: Reports" (https://www.fda.gov/drugs/postmarketing- requirements-and-commitments-introduction/postmarketing-requirements- and-commitments-reports).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The text outlines postmarketing requirements (PMRs) and commitments (PMCs) that drug and biologics firms must comply with, affecting operational protocols and regulatory reporting by these firms. Compliance can influence market access and financial planning as firms must allocate resources for regulatory adherence.