FDA Related News

Human Drugs

Guide on Using Prior Knowledge for Genome Editing Gene Therapies

FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufacturing knowledge to s...

FDA Challenged to Keep Up With ALS Therapies

Former FDAer Peter Pitts says the agency must become more consistent in its application of innovative review methods to keep pace with changes in cont...

Human Drugs

Drop Rabbit Pyrogen Test References: Petition

Animal Defenders International petitions FDA to remove all references to rabbit pyrogen testing from its regulations and permit the use of validated n...

Biologics

FDA Orders Takeda to Add Boxed Warning to Adzynma

FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition of a Boxed Warning, a...

Human Drugs

FDA Names Veteran Investigator as Head of Inspections/Investigations

FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency veteran to one of t...

Human Drugs

Fulcrum Therapeutics Halts Sickle Cell Disease Program

Fulcrum Therapeutics says it is discontinuing development of its lead sickle cell disease candidate, pociredir, after receiving feedback from FDA.The ...

Biologics

CBER Post New E-Submission Frequently Asked Questions Guide

FDA posts a new set of frequently asked questions (FAQ) aimed at helping companies navigate the electronic submission process for products regulated b...

FDA General

Be Prepared for New One-Day FDA Inspections: Law Firms

Law firms Hogan Lovells and Foley and Lardner advise pharmaceutical and medical device companies to maintain full inspection readiness while FDA under...

FDA General

Former FDA and HHS Heads Opine on Next Commissioner

Former FDA commissioner Andrew C. von Eschenbach and former HHS secretary Tommy G. Thompson urge policymakers to prioritize leadership and institution...

FDA General

Report Urges FDA Overhaul for Faster Reviews

A new policy report urges sweeping FDA reforms, arguing that shortening the time required to bring drugs, biologics and medical devices to market coul...