JD Supra

Q&A: FDA Seeks to Clarify '3-Year Exclusivity' with New Guidance

In March 2026, the Food and Drug Administration (FDA) issued draft guidance for the industry, New Clinical Investigation Exclusivity ...
JD Supra

FDA’s Revised Biosimilar Q&As: Three Things Sponsors Should Know

In early March 2026, the U.S. Food and Drug Administration (FDA) issued updates to its Q&A guidance interpreting and implementing the Biologics ...
Hosted on MSN

FDA questions common practice of getting covid, flu vaccines together

The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...
Opinion
HealioOpinion

Editorial: Why the FDA’s move away from animal testing is scientifically necessary

The FDA’s recent announcement to reduce, and in some cases replace, animal testing for monoclonal antibodies and other therapeutics represents one of the most consequential regulatory developments in ...
PharmTech

From Guidance to Operating Model: Preparing CMC and Quality Systems for FDA's Digital-by-Default Oversight

Taken together, these signals operationalize a data-centric oversight model. They also raise a practical question for CMC and quality leaders: if evidence is increasingly remote-ready and ...