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Medical Devices

CDRH Early Feasibility Study Program

CDRH releases an online information sheet on its Early Feasibility Study program.

Human Drugs

Centurion Labs Recalls Ninjacof and Ninjacof A

Centurion Labs recalls one lot of Ninjacof and one lot of Ninjacof A manufactured by Vilvet and distributed by Centurion Labs to the retail level due ...

FDA General

Sherman Named Gottliebs Top Deputy

FDA Deputy Commissioner and Office of Medical Products and Tobacco director Rachel Sherman accepts the position principal deputy commissioner.

Human Drugs

Ultragenyx Ace-ER Fails Phase 3 Study

Ultragenyx says it will terminate development of aceneuramic acid extended release after it failed to meet key primary and secondary endpoints in a Ph...

Federal Register

Comments Sought on OTC Drugs Under GRASE

Federal Register notice: FDA seeks comments on an information collection related to Additional Criteria and Procedures for Classifying Over-the-Counte...

Federal Register

Advisory Committee to Review PTC Therapeutics NDA

Federal Register notice: FDA announces a 9/28 Peripheral and Central Nervous System Drugs Advisory Committee meeting to review a PTC Therapeutics NDA ...

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Bicooya Cosmetics Ltd. and ImprimisRx.

Human Drugs

Declare Elysium Health Basis Supplement Adulterated: ChromaDex

ChromaDex asks FDA to declare Elysium Healths Basis supplement product to be adulterated because it uses an ingredient that is not generally recognize...

Federal Register

Comments Sought on Informed Consent Exception for Diagnostics

Federal Register notice: FDA is seeking comments on an information collection extension for Medical Devices; Exception From General Requirements for I...

Federal Register

Pediatric Advisory Committee to Conduct Safety Reviews

Federal Register notice: FDA announces a 9/11-12 Pediatric Advisory Committee meeting in Rockville, MD to conduct pediatric-focused safety reviews.