FDA Related News

Federal Register

FDA Withdraws Miles Laboratories ANDA

Federal Register notice: FDA withdraws a Miles Laboratories ANDA for alcohol and dextrose injection, 5 mL/100 mL because the agency has scientific dat...

Human Drugs

Product-Specific Guidance Meetings

FDA publishes a draft guidance with information on requesting and conducting product-specific guidance meetings between FDA and ANDA applicants.

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.