FDA Related News

Biologics

FDA Authorizes Pfizer Bivalent Vaccine for Young Children

FDA amends the emergency use authorization for the Pfizer-BioNTech Covid-19 bivalent vaccine and its use as a single booster dose to include children ...

FDA General

FDA Webview Reaches Out for Your Guidance

Still evolving under the same leadership, Dickinsons FDA Webview asks subscribers to help guide our further development and improve service.

Medical Devices

FDA Clears PeekMed Orthopedic Surgery Planner

FDA clears a PeekMed 510(k) for its Web-based artificial intelligence automated planning solution for use in orthopedic surgery.

Human Drugs

Most Drug Shortages are Manufacturing Related: FDA

FDA says the main causes of drug shortages continue to be manufacturing quality issues and manufacturing production delays.

Human Drugs

FDA Clinical Hold on Mersana Tumor Drug

FDA places a clinical hold on Mersana Therapeutics Phase 1 trial of XMT-2056 after the company suspended it due to a recent patient death that was dee...

Human Drugs

Guide on Gastric pH-Dependent Drug Interactions

FDA posts a final guidance entitled Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and C...

Human Drugs

Acadia Drug for Rett Syndrome Approved

FDA approves an Acadia Pharmaceuticals NDA for Daybue (trofinetide) oral solution for treating Rett syndrome.

Biologics

FDA/CDC Correct Florida Officials Vaccine Misinformation

FDA and CDC send a letter to Florida surgeon general Joseph Ladapo to correct his misinterpretations and misinformation about Covid-19-related data.

Human Drugs

GAO Report Hits FDA on Advanced Manufacturing Tracking

A new Government Accountability Office report recommends that FDA better track the extent of its efforts to encourage drug manufacturers to adopt adva...

FDA Outlines Disposition of Covid-19 Guidances

FDA publishes a Federal Register notice outlining the status of the many guidance documents that were issued to address the Covid-19 public health eme...