FDA Related News

Medical Devices

Avita Skin Defect Device Get Expanded Use

FDA approves an Avita Medical PMA supplement for use of its Recell System to treat full-thickness skin defects.

Federal Register

Buspar Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Bristol Myers Squibbs Buspar (buspirone HCl) was not withdrawn due to safety or effectiveness reasons.

Federal Register

Info Collection Extension of Drug Import Plans

Federal Register notice: FDA seeks comments on an information collection extension entitled Importation of Prescription Drugs 21 CFR Part 251.

Federal Register

Antimicrobial Drugs Panel Renewed

Federal Register notice: FDA renews its Antimicrobial Drugs Advisory Committee for an additional two years.

Human Drugs

FDA Taps Murphy to Head Generic Drugs Office

FDA names CDER Office of Generic Drugs safety and clinical evaluation acting director Iilun Murphy as the next OGD director, replacing Sally Choe, who...

Human Drugs

FDA Approves Production at BMS CAR T Facility

FDA greenlights commercial production of CAR T cell therapy at a new Bristol Myers Squibb manufacturing site in Devens, MA.

Human Drugs

Panel Backs RSV Monoclonal Antibody

FDAs Antimicrobial Drugs Advisory Committee votes unanimously that AstraZeneca and Sanofis nirsevimab has a favorable benefit-risk assessment for prev...

Create One PPI Guidance for all Products: Novartis

Novartis urges FDA to broaden its proposal on patient preference information beyond medical devices.

Human Drugs

Assessing GDUFA User Fees Guidance

FDA publishes a guidance with specifics about changes to user fees imposed under the GDUFA 3 reauthorization in 2022.

Human Drugs

FDA OKs Novaliq Dry Eye Drug

FDA approves a Novaliq NDA for Vevye (cyclosporine ophthalmic solution) 0.1% for treating the signs and symptoms of dry eye disease.