FDA Webview
Human Drugs
FDA grants OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall s...
Human Drugs
An FDA approval document shows that the accelerated approval of Replimunes Tudriqev came despite sig...
Medical Devices
FDA grants a humanitarian-use device designation to Cyberkinetics Neurotechnology Systems for its An...
Human Drugs
FDA has issued a warning letter to a Telangana, India, sterile drug manufacturing facility operated ...
FDA General
Consulting editor John Scharmann receives an FOI response from FDA that is five years late and says ...
Human Drugs
FDAs Oncologic Drugs Advisory Committee votes to not recommend approval for a Genta NDA for leukemia...
Human Drugs
CDC says FDA has helped manufacturers prepare to ship a record volume of flu vaccine this season.
Medical Devices
Boston Scientific acknowledges an internal study found an increased risk of late stent thrombosis wi...
Federal Register
Federal Register Notice: FDA releases a draft guidance on frequently asked questions about commercia...
Medical Devices
FDA has given 510(k) clearance to Trinity Biotech for its Uni-Gold H. pylori one-step test. Company ...
Medical Devices
C.R. Bard, Inc., Murray Hill, NJ, has received 510(k) clearance from FDA for its Memotherm Flexx bil...
Human Drugs
Escalon Medical Corp. has discontinued Phase I human clinical trials for its Ocufit SR ophthalmic dr...
Medical Devices
Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may all...
Human Drugs
FDA approves Lantheus Holdings Tauklarify (florquinitau F 18 injection) as a PET imaging agent to id...
Human Drugs
Cephalon says it plans to submit an NDA in the third quarter for Treanda, indicated for treating chr...
Animal Drugs
Federal Register Notice: 12/29. The Office of Management and Budget approved a collection of informa...
Human Drugs
Perrigo Company, Allegan, MI, recalled 4,473,600 acetaminophen tablets extra strength, 500 mg, packa...
Federal Register
Federal Register Notice: FDA releases a draft guidance on in vitro diagnostic mulivariate index assa...
Human Drugs
Cortex Pharmaceuticals submits a complete response to an FDA clinical hold on its lead Ampakine comp...
Animal Drugs
Federal Register Final rule: 12/17. FDA approved Pharmacia & Upjohn Co.'s supplemental new animal dr...
