FDA Related News

Califf Sees Misinformation as Cause of Preventable Deaths

FDA commissioner Robert Califf announces a project to explore ways the agency can respond to and counter misleading health information in a variety of...

Medical Devices

Zephyrus Safety Syringe Cleared

FDA clears a Zephyrus Innovations 510(k) for its Aerojec 3ml safety syringe.

Human Drugs

FDA OKs Apellis Syfovre for Geographic Atrophy

FDA approves Apellis Pharmaceuticals Syfovre to treat geographic atrophy secondary to age-related macular degeneration.

Federal Register

Guide on Compounding Ibuprofen Oral Suspension

Federal Register notice: FDA makes available a final guidance on compounding certain ibuprofen oral suspension products.

Federal Register

2 Meetings on Adverse Event Reporting

Federal Register notice: FDA announces two public meetings on electronic submission of adverse event reports using International Council for Harmoniza...

Medical Devices

GE Recalls Unstable Nuclear Medicine Devices

GE HealthCare recalls its Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent uncontrolled detecto...

Human Drugs

Drug R&D Cant Justify High Prices: Study

UK-based researchers say their analysis of drug company financial records doesnt support company claims that high drug prices are needed to support re...

Human Drugs

Further FDA Opioid Crisis Strategies: Califf

FDA commissioner Robert Califf outlines ways the agency is taking additional steps as part of its response to the nations opioid crisis.

Human Drugs

30 New Product-Specific Guidances Out

FDA releases a batch of 30 new and revised product-specific guidances to aid in the development of generic drugs.

Human Drugs

Pfizer Says Talzenna Prostate Cancer Study Positive

Pfizer says FDA has granted priority review for its sNDA for Talzenna and Xtandi which showed positive results in a Phase 3 study for treating metasta...