Health AffairsOpinion

Refining FDA’s Plausible Mechanism Framework, Part 2: Manufacturing Challenges, Product Scope, And Post-Approval Considerations

This is part two of a two-part article offering proposals to improve the FDA’s draft guidance to implement a new approval ...
National Academies of Sciences%2c Engineering%2c and Medicine

Challenges for the FDA: The Future of Drug Safety: Workshop Summary

Recommendation 4.11 The committee recommends that Congress require industry sponsors to register in a timely manner at clinicaltrials.gov, at a minimum, all phase 2 through 4 clinical trials, wherever ...
Health Affairs

The FDA Amendments Act And Drug Safety: Where Are We Twenty Years Later?

Nearly two decades ago, Congress passed the US Food and Drug Administration (FDA) Amendments Act of 2007 , partially in ...
JD Supra

FDA’s Draft Guidance for Cosmetics Industry Explains Records-Access Authority During Inspections

The U.S. Food and Drug Administration (FDA) has issued a draft guidance reminding the cosmetics industry that the agency can access a variety of business records ...
JD Supra

FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can ...
The American Journal of Managed Care

FDA to Convene Expert Panel on Expanding Access to Peptides Amid Safety, Regulatory Debate

The July 2026 advisory review could reopen compounding pathways for peptides previously curtailed in 2023 over immunogenicity, toxicity, impurity risk, and inadequate human clinical evidence.