FDA Related News

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes CGA Limited, Curewave Lasers, Tismor Health and Wellness, Vevazz and Zhuhai Aofute Medi...

Biologics

FDA Approves Horizons Rare Eye Disease Drug

FDA approves a Horizon Therapeutics BLA for Tepezza (teprotumumab-trbw) for treating adults with thyroid eye disease.

Human Drugs

GAO on More Drug Development Machine Learning

A Government Accountability Office report describes six policy options for overcoming challenges to increasing the use of machine learning in drug dev...

Office of New Drugs Name Changes

CDER says names of the Office of New Drugs offices and divisions were changed as part of its reorganization.

Human Drugs

CGMP Violations at Tismor Health and Wellness

FDA warns Australias Tismor Health and Wellness about CGMP and other violations in its work as a contract manufacturer of finished drugs.

Federal Register

Info Collection on Radioactive Research Committees

Federal Register notice: FDA seeks comments on an information collection extension for Radioactive Drug Research Committees21 CFR 361.1.

Federal Register

Info Collection on Customer Service Surveys

Federal Register notice: FDA seeks comments on an information collection extension for Customer/Partner Service Surveys (OMB Control Number 09100360)....

Medical Devices

CureWave Lasers Marketing Unapproved Device: FDA

FDA warns CureWave Lasers about multiple violations in its manufacturing and marketing of laser products.

Federal Register

Consumer Reps Sought for Advisory Panels

Federal Register notice: FDA requests that any consumer organizations interested in participating in selecting voting or nonvoting consumer representa...

Federal Register

FDA Rare Disease Day Public Meeting

Federal Register notice: FDA announces a 2/24 public meeting on FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development....