The 7th Circuit Court of Appeals affirms a lower court decision dismissing a suit charging that AbbVies filing of 132 additional Humira patents violat...
Federal Register notice: FDA seeks comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling change...
Speaking at an Alliance for a Stronger FDA Webcast, FDA principal deputy commissioner Janet Woodcock says FDA is working toward new efficiencies throu...
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...
