FDA Related News

Medical Devices

Abbott Deep Brain Depression Device is Breakthrough Device

FDA grants breakthrough device designation to the Abbott deep brain stimulation system for use in treatment-resistant depression.

Human Drugs

Pharmacists Can Prescribe Paxlovid: FDA

FDA says state-licensed pharmacists may prescribe Paxlovid but not Lagevrio.

Medical Devices

FDA Clears VideaHealth Dental Cavity AI Algorithm

FDA gives 510(k) clearance to a VideaHealth algorithm that can help dentists identify dental caries on patient X-rays.

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Comments on Medical Device VIP Program Draft Guidance

Six stakeholders comment on an FDA draft guidance on the CDRH Voluntary Improvement Program for medical device manufacturers.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