FDA Related News

Medical Devices

Philips Ultrasound Options Cleared for Covid-19

FDA clears a Royal Philips 510(k) for ultrasound options for managing Covid-19-related lung and cardiac complications.

Biologics

Sparrow Health Selling Unapproved Cell Products: CBER

A CBER notice of violation says Sparrow Health & Performance is providing unapproved adipose tissue-derived cellular products to treat many diseases a...

Human Drugs

Fusion Health Sold Unapproved Covid Products: FDA

FDA warns Fusion Health and Vitality that it sold unapproved, misbranded drug products intended to treat Covid-19.

Human Drugs

FDA Updates Purple Book on Biologics

FDA updates its Purple Book: Database of FDA-Licensed Biological Products to add all FDA-licensed, biological products regulated by CDER.

FDA, CDC Working on Plan to Reopen Inspections

FDA commissioner Stephen Hahn says his agency is working with the CDC on a science-driven process to restart on-site surveillance inspections when app...

FDA Updates Covid Clinical Trial Guidance

FDA says it has updated the question-and-answer appendix in its guidance on conducting medical product clinical trials during the public health emerge...

Human Drugs

CDER Recommendations on IND Inquiries for Covid Drugs

CDER outlines recommendations for drug sponsors seeking product development inquiries for Covid-19 products.

Biologics

Moderna Covid-19 Vaccine Gets Fast Track

FDA grants Moderna a fast track designation for its mRNA vaccine candidate (mRNA-1273) for Covid-19.

Human Drugs

Multiple Violations at Nephron Pharmaceuticals

FDA releases an FDA-483 with nine observations from an inspection at Nephron Sterile Compounding Center.

Human Drugs

Court Backs FDA in PMRS Opioid Drug Case

The DC Circuit Court of Appeals says FDA acted properly in denying a PMRS NDA for an opioid product that claimed abuse-deterrent properties and reject...