FDA Related News

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

Cingulate Gets FDA Complete Response Letter on ADHD Drug

FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity di...

Medical Devices

Early Alert on Abiomed Introducer Kits Due to Serious Injuries

FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with the companys Impella ...

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...

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...