CDRH director Jeffrey Shuren describes Center efforts to help sterilization facilities to reduce ethylene oxide emissions into the environment.
FDA approves Allergan Aesthetics Juvderm Volux XC for improving jawline definition in adults over the age of 21 with moderate to severe loss of jawlin...
Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies...
FDA approves Coherus Cimerli as an interchangeable generic version of Genentechs Lucentis for all five label indications.
A Grid news report uses Linkedin data to estimate how many former FDAers are now working in regulated companies and discusses the ethical issues raise...
Alnylam Pharmaceuticals plans to file an NDA submission late this year for patisiran, indicated for treating transthyretin-mediated amyloidosis with c...
Federal Register notice: FDA announces a 9/7 Peripheral and Central Nervous System Drugs Advisory Committee meeting that will review Amylyx Pharmaceut...
FDA clears a Glaukos 510(k) for its iStent Infinite Trabecular Micro-Bypass System and its use in a standalone procedure to reduce elevated intraocula...
