FDA Grades Pharma's Homework on Post-Approval Promises
Published Date: 5/30/2025
Notice
Summary
The FDA just released its yearly report on how drug and biologics companies are doing with their promised follow-up studies after approval. This report affects companies that make these products and helps everyone see if they’re keeping their promises to keep medicines safe. Check it out online anytime to see the latest updates—no extra cost or waiting needed!
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA posts annual postmarketing report
The FDA published its annual report titled "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments" under the Federal Food, Drug, and Cosmetic Act. The report shows the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs), including studies and clinical trials that application holders are required or have agreed to conduct, and is available on FDA's website anytime at no cost.
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