FDA Related News

Federal Register

Guide on Drug Carcinogenicity Testing

Federal Register notice: FDA makes available a draft guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.

Medical Devices

Marci Beauty Selling Unapproved Light Therapy Devices: FDA

FDA warns Marci Beauty it is marketing seven unapproved light therapy devices.

Medical Devices

Class 1 Recall of Medtronic Insulin Pumps

FDA classifies as Class 1 a Medtronic recall of certain insulin pumps that was initiated to replace any pump that has a clear retainer ring due to pot...

Former FDAer Leading Agilis Consulting

Agilis Consulting names former FDA human factors team leader Shannon Hoste as president.

Human Drugs

FDA Study Shows Path to Uninterrupted Drug Supply

An FDA/HHS-funded University of Maryland study identifies factors that it says can lead to an uninterrupted supply of drugs for the U.S.

Biologics

J&J Seeks EUA for Booster Jab

Johnson & Johnson files data to support an emergency use authorization for its Covid-19 booster shot in those 18 years of age and older.

Human Drugs

4 Device De Novo Guidances Revised

FDA revises four guidance documents based on a final rule on the medical device de novo classification process.

Human Drugs

AZ Wants EUA for Covid Prophylaxis Drug

AstraZeneca applies for an FDA emergency use authorization for a long-acting antibody combination as a Covid-19 prophylaxis.

Medical Devices

Medtronic Expands Class 1 Remote Controller Recall

FDA says Medtronic has expanded its recall of insulin pump remote controllers due to cybersecurity risks.

FDA Promoting Advanced and Smart Manufacturing

FDA releases a report calling for accelerating the adoption of advanced and smart manufacturing technologies.