FDA Related News

Human Drugs

FDA New Product-Specific Guidances

FDA publishes 46 new or revised product-specific guidances to spur the development of generic drugs.

FDA General

Appropriators Cut FDA Budget by $600 million

A House Appropriations Subcommittee cuts FDAs fiscal year 2024 budget request by $600 million (8.3%).

Biologics

Panel Backs Pfizers RSV Vaccine

FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend approval of a Pfizer BLA for its Abrysvo (RSVpreF) vaccine for pre...

Human Drugs

2 Pediatric Drug Approval Guidances

FDA publishes two guidances to assist in the development of drugs, biologics, and vaccines for pediatric use.

Human Drugs

Partial Hold Modified in Myotonic Dystrophy Study

FDA modifies a partial clinical hold on an Avidity Biosciences study involving AOC 1001, allowing Avidity to double the number of participants in the ...

Human Drugs

ICU Medical Recalls Pumps Over Battery Defect

ICU Medical recalls the replacement batteries in its in Plum A+ & Plum A+3 Infusion Systems due to a manufacturing defect by a battery supplier.

Federal Register

Susceptibility Test Interpretive Criteria Updated

Federal Register notice: FDA posts its annual compilation of notices of updates to the agencys antimicrobial test interpretive criteria Web page.

Federal Register

Device Panel to Tackle Health Equity

Federal Register notice: CDRH plans a 9/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on advancing health...

Human Drugs

Reviewers Question Intercepts Liver Drug

FDA asks the Gastrointestinal Drugs Advisory Committee whether it recommends approval of Intercepts obeticholic acid to treat pre-cirrhotic liver fibr...

Bill to Use Industry Penalties for Cancer Research

A bipartisan group of members of Congress introduce legislation to redirect penalties paid by drug, cosmetic, supplement, and medical device companies...