FDA Related News

Human Drugs

2 Draft DSCSA Guidances Out

FDA publishes two draft guidances revising previous Drug Supply Chain Security Act guidances.

Human Drugs

FDA Warns 5 Kratom Distributors

FDA warns five companies that they are illegally distributing kratom products that are unapproved new drugs.

Human Drugs

FDA Lifts Vertex Stem Cell Therapy Clinical Hold

FDA lifts its clinical hold on Vertex Pharmaceuticals VX-880 stem cell therapy for type 1 diabetes.

Human Drugs

No Zyesami EUA: FDA

FDA declines to approve an emergency use authorization for NRx Pharmaceuticals Zyesami in some critical Covid-19 patients.

Human Drugs

FDA Advisors to Reconsider Amylyx ALS Drug

The FDA Peripheral and Central Nervous System Drugs Advisory Committee meets on 9/7 to consider new information from Amylyx on its ALS drug that the c...

Medical Devices

FDA Posts eMDR Enhancements

FDA lists enhancements to the CDRH electronic medical device reporting system and sets a schedule for future changes.

Federal Register

Patient-focused Drug Guide Docket Correction

Federal Register notice: FDA corrects the docket number associated with a 6/30 notice on a draft guidance entitled Patient-Focused Drug Development: S...

Human Drugs

Genetic Evidence Supports Many FDA Drug Approvals: Study

UK researchers say genetic evidence supports two-thirds of drugs FDA approved in 2021.

Federal Register

Federal Register Notices Week of July 4

FDA Webview posts the Federal Register notices that published during the week of our annual Fourth of July (Independence Day) holiday break.

Bill Introduced to Ban Misleading DTC Ads

U.S. Rep. Abigail Spanberger (D-VA) introduces the Banning Misleading Drug Ads Act that is intended to prevent manufacturers from obscuring dangerous ...