FDA Related News

Human Drugs

Preemption in FDA Monograph OTC Cases Explained

Two Covington & Burley attorneys review the history of court preemption decisions involving over-the-counter drug monograph products.

Human Drugs

FDA Self-Audit Sees Continuous Manufacturing Advantages

CDER Office of Pharmaceutical Quality deputy director Mahesh Ramanadham outlines advantages found in an agency self-audit comparing regulatory actions...

Federal Register

FDA Withdraws Xellias Bacitracin ANDA

Federal Register notice: FDA withdraws the approval of Xellia Pharmaceuticals ANDA for bacitracin for injection after the company requested that it be...

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Comments on Medical Device VIP Program Draft Guidance

Six stakeholders comment on an FDA draft guidance on the CDRH Voluntary Improvement Program for medical device manufacturers.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