FDA Related News

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.

Federal Register

Notice Withdrawn on Review Voucher Issued in Error

Federal Register notice: FDA withdraws a 9/30 notice that announced in error the issuance of a priority review voucher to a rare pediatric disease pro...

Federal Register

Updated Covid-19 Guidance Listing Available

Federal Register notice: FDA updates its listing of available guidance documents related to the Covid-19 public health emergency.

Federal Register

Workshop on Disease Progression Models

Federal Register notice: FDA announces an 11/19 public workshop entitled Best Practices for Development and Application of Disease Progression Models....

Human Drugs

Courts Forcing FDA to Reconsider Orphan Drug Designation: Analysis

Two Hyman, Phelps attorneys explain the orphan drug designation issues facing FDA in light of appeals court decisions against the agency.