FDA Related News

Human Drugs

Biogen Sued for Aduhelm Securities Fraud

An Oklahoma pension fund initiates a securities fraud class action suit against Biogen and its top executives over the controversial Aduhelm approval.

Human Drugs

BIO Recommendations for RWD Guidance

The Biotechnology Innovation Organization recommends changes to an FDA draft guidance on data standards for real-world data in drug and biological pro...

FDA Digital Health Technology Guidance

King & Spaulding attorneys praise an FDA draft guidance on using digital health technologies in clinical investigations.

Human Drugs

PDA Comments on Remote Interactive Evaluations

The Parenteral Drug Association recommends changes to an FDA guidance on remote interactive evaluations of drug manufacturing and bioresearch monitori...

Medical Devices

FDA Rejects Pulse Bio Expanded Use on CellFX

FDA rejects a Pulse Biosciences 510(k) for an expanded indication to treat sebaceous hyperplasia with its cleared CellFX System.

Medical Devices

Ex-FDA Orthopedic Device Reviewer Joins NDA Partners

Former CDRH orthopedic device medical officer Stephen Weber joins consultant group NDA Partners.

Medical Devices

Warning on Enteral Feeding Child Strangulation

FDA warns health care providers and parents who receive enteral feeding that there is a risk of strangulation from using enteral feeding delivery sets...

Federal Register

Clin-Pharm Guide on Antibody-Drug Conjugates

Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Antibody-Drug Conjugates.

$5.6 Billion in FY 2021 FCA Settlements, Judgments

The Justice Department says it collected more than $5.6 billion in settlements and judgments under the False Claims Act in FY 2021, with more than $5 ...

Federal Register

Gas-Controlled Tissue Expander is Class 2

Federal Register notice: FDA classifies carbon dioxide gas-controlled tissue expanders into medical device Class 2 (special controls).