BioWorld

FDA’s CDER helmless again, amid bribery, defamation claims

The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George ...
JD Supra

FDA readies for QMSR implementation with draft QMS information guidance: What manufacturers need to know

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
Clinical Advisor

FDA to Ease Copycat Drug Rules, Speeding Access to Cheaper Drugs

Developers of biosimilars -- medicines that are near-identical copies of biologic drugs -- will no longer be required to conduct clinical trials to prove effectiveness.
JD Supra

Shutdown Updates, FDA Orphan Drug Leader Reassigned as CMS Issues Orphan Drugs Guidance, FDA to Host Allergen Threshold Meeting, and Commissioner’s National Priority Review ...

Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), ...

REPEAT — Nutriband Announces Successful Meeting Completed With United States FDA For Its Abuse Deterrent Fentanyl Patch

Nutriband met with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL (abuse deterrent ...