FDA Related News

Medical Devices

Legislation for More AI/ML Flexibility Needed: Shuren

CDRH director Jeffrey Shuren says legislation is needed to provide more regulatory flexibility and agility to deal with artificial intelligence/machin...

Biologics

Former FDA Vaccine Official Joins Mesoblast Board

Former CBER Office of Vaccines Research and Review deputy director Philip Krause joins Mesoblasts board of directors and will assist the company in ga...

Human Drugs

FDA Schedules Generic Drug Forum

FDA announces the dates and program for the Generic Drugs Forum 2022.

FDA Approves Novartis Pluvicto for Prostate Cancer

FDA approves Novartis Pluvicto for treating some prostate cancers and approves a radioactive diagnostic agent to identify candidates for Pluvicto ther...

Human Drugs

Amylyx ALS Drug May Cause FDA Problems: AP

An Associated Press report says an upcoming FDA advisory committee meeting to consider an Amylyx drug to treat ALS may raise issues similar to those p...

Human Drugs

PharmaTher to Work with FDA on Ketamine Phase 3 Study

PharmaTher says it will work with FDA toward a Phase 3 trial of its ketamine infusion to treat levodopa-induced dyskinesia in Parkinsons patients.

Human Drugs

Top Warning Letter Drug GMP Citations

CDER Office of Manufacturing Quality branch chief Maan Abduldayem outlines the Centers Top Recent Warning Letter Citations (FY 2019 to FY 2021).

Federal Register

Obstetrics, Reproductive Drugs Panel Renewed

Federal Register notice: FDA renews its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years.

Medical Devices

Artio Medical Embolization Device Cleared

FDA clears an Artio Medical 510(k) for its Solus Gold Embolization Device for peripheral vascular occlusion.

Human Drugs

Complete Response Letter for Takedas Natpara

FDA issues a complete response letter saying it cannot approve at this time a Takeda prior approval supplement for its Natpara hypoparathyroidism medi...