JD Supra

FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

In October 2025, the FDA released a revised guidance titled, “Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers.” ...
Fierce Biotech

FDA issues draft guidance to reduce primate testing for certain antibodies

The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...
STAT

A dozen former FDA commissioners decry Prasad memo on vaccine regulation

Changes to the ways in which the FDA plans to regulate vaccines represent a threat to effective vaccines and public health, ...
Fierce Pharma

FDA's Prasad tells staffers agency plans to get tougher on vaccine regulation, blames child deaths on COVID shots

In the wake of the memo, several vaccine experts responded that the CBER director's claim about the deaths requires more ...
JD Supra

FDA Issued Updated Patient-Focused Drug Development Guidance on Clinical Outcome Assessments

In its latest PFDD installment, the FDA offers a detailed roadmap for sponsors seeking to design, adapt, or validate COAs that accurately ...
Fierce Pharma

A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes

Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from ...
The Well News on MSN

FDA Draft Guidance Places New Limits on Toxicity Tests Involving Primates

WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...

FDA changes heads of drug research and OTC drugs in latest shake-up

The U.S. Food and Drug Administration (FDA) has been rocked by recent changes to several leadership roles while it has ...

Twelve former US FDA commissioners express deep concern about agency's vaccine change

Twelve former U.S. FDA commissioners said on Wednesday they were deeply concerned about proposed changes to vaccine ...
BioSpace

FDA Moves to Cut Back on Testing Antibodies on Primates

For certain monospecific antibodies, three-month toxicology studies plus other supportive evidence will suffice, eliminating ...

Ex-FDA commissioners slam Trump admin vaccine plan

A dozen former leaders of the U.S. Food and Drug Administration (FDA) slammed the Trump administration Wednesday over its ...
The Regulatory Review

Evaluating FDA Preemption of State Drug Regulation

Scholars argue that federal drug agency actions should take precedence over conflicting state regulations. How should courts handle state regulations that restrict access to pharmaceuticals previously ...