FDA Related News

Medical Devices

Comments on Medical Device VIP Program Draft Guidance

Six stakeholders comment on an FDA draft guidance on the CDRH Voluntary Improvement Program for medical device manufacturers.

Human Drugs

Intercept to Resubmit Obeticholic Acid NDA

Intercept Pharmaceuticals says it will resubmit an NDA to FDA for its obeticholic acid to treat patients with liver fibrosis due to nonalcoholic steat...

Medical Devices

Getinge USA Anesthesia System Recall is Class 1

FDA says a Getinge USA anesthesia system recall due to cracked or broken suction power switches is Class 1.

Mylan Recalls 1 Batch of Insulin Pens

Mylan recalls one batch of unbranded insulin glargine pens due to the potential for some pens to be missing the label.

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.