FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Biologics

Merck Pneumococcal Vaccine Hits Phase 3 Marks

Merck says its investigational V116 21-valent pneumococcal conjugate vaccine hit key immunogenicity and safety endpoints in two Phase 3 trials in adul...

latest-news-card-1
FDA General

House Delays FDA Budget Floor Vote

House GOP leadership delay a floor vote on FDAs fiscal year 2024 budget bill until lawmakers return from their August recess.

Medical Devices

UltraSight Ultrasound Guidance Software Cleared

FDA clears an UltraSight 510(k) for its artificial intelligence-powered ultrasound guidance technology.

latest-news-card-1
Federal Register

Contact Lens Care Product Guidance

Federal Register notice: FDA makes available a final guidance entitled Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommend...

latest-news-card-1
Federal Register

Guide on Drug Quality Consensus Standards

Federal Register notice: FDA makes available a final guidance entitled CDERs Program for the Recognition of Voluntary Consensus Standards Related to P...

latest-news-card-1
Medical Devices

Fentanyl Detection Kit Gains Clearance

FDA clears a Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human urine.

latest-news-card-1
Federal Register

Panel to Review BrainStorm ALS Submission

Federal Register notice: FDA announces a 9/27 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to discuss a BrainStorm Therapeutics sup...

latest-news-card-1
Federal Register

FDA Debars Daffin Over Covid Treatments

Federal Register notice: FDA permanently debars Diana Daffin from providing services in any capacity to a person that has an approved or pending drug ...

latest-news-card-1
FDA General

Integrating ORA in Centers Has Risks: Analysis

Attorney Tim Philips outlines best- and worst-case scenarios in the coming ORA reorganization.

latest-news-card-1
Human Drugs

Recall Unapproved Phenobarb Products: Sun

Sun Pharma asks FDA to seek recalls of unapproved phenobarbitol products and notify healthcare providers and consumers of the dangers of those product...