Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that address bioequivalence study design re...
Charles River Laboratories petitions FDA to exercise regulatory oversight over both natural and synthetic endotoxin contamination assays.
Attorney and data scientist Bradley Thompson says FDA data support the value of a breakthrough device designation for de novo submissions but not for ...
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Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies...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...
