FDA Related News

Human Drugs

Engineer Says FDA Stifles Pharmaceutical Innovation

Aerospace engineer Robert Zubrin writes in National Review that FDA is an over-regulating federal bureaucracy gone mad.

Human Drugs

Another FDA Political Appointee Falls in House Cleaning

FDA commissioner Stephen Hahn removes associate commissioner for external affairs John Wagner as part of the purge to right the ship in the wake of Ha...

Human Drugs

NIH Covid-19 Panel Refutes FDA Plasma EUA

An NIH Covid-19 treatment guideline panel refutes FDAs recent decision to grant an Emergency Use Authorization (EUA) for convalescent plasma for treat...

Human Drugs

Mylan Recalls Amiodarone HCl and Tranexamic Acid

Mylan recalls four lots of amiodarone HCl injection, USP 450 mg/9 mL, and tranexamic acid injection, USP 1000 mg/10 mL due to potential labeling mix-u...

Human Drugs

Orange Book Listings Need Clarification: Comments

Three stakeholders say FDA should provide additional clarification on the rules for listing patents in the Orange Book.

Federal Register

KV Pharmas Micro-K LS Not Withdrawn Over Safety/Efficacy

Federal Register notice: FDA determines that KV Pharmaceuticalֺs Micro-K LS (potassium chloride) extended-release liquid suspension, 20 milliequ...

Federal Register

Federal Register Corrected in NDA Withdrawals

Federal Register notice: FDA corrects a 5/14 Federal Register notice on 16 NDA withdrawals from multiple applicants.

Federal Register

Pediatric Post-marketing Drug Safety Reviews

Federal Register notice: FDA establishes a public docket to collect comments related to post-marketing pediatric-focused safety reviews of products po...

FDA Denies Nitric Oxide Petition

FDA denies two of three requests from a petition challenging the clearance and approval of certain nitric oxide products.

Medical Devices

Alaris Hardware Recall Class 1, 2

FDA says three of four problem scenarios described by Becton Dickinson in its recall of Alaris infusion pumps are Class 1.