Most FDA-approved drugs meet postmarketing study requirements, and advisory panel backs two peptides for bulk compounding

A recent analysis published in JAMA Network Open found that nearly nine out of ten drugs approved by the U.S. Food and Drug Administration have completed their postmarketing requirements or commitments. These obligations were assigned at the time of approval and most sponsors fulfilled them.

The study also reported that the vast majority of the completed studies had their results posted on ClinicalTrials.gov or published in other scientific outlets, indicating a high level of transparency.

In a separate regulatory action, an FDA advisory committee voted 8-6 with one abstention to recommend adding two peptide drugs, BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions, to the 503A Bulks List for bulk compounding.

If adopted, the recommendation could expand compounding options for these peptides, potentially affecting how they are manufactured and distributed to patients.