A McDermott Will & Emery review of FDA activities in 2019 finds a slight decrease in overall enforcement activity as the agency continues focusing on ...
FDA approves a Lannett Co. NDA for cocaine hydrochloride nasal solution 4% (40 mg/mL), indicated for the introduction of local anesthesia in the mucou...
FDA asks members of the Anesthetic and Analgesia Drug Products Advisory Committee to evaluate whether Durect has provided sufficient efficacy and safe...
FDA staffers discuss the future role of machine learning in drug development and regulation.
CDRH associate director Erin Keith says the Center will be issuing more Warning Letters now that staff are getting used to an internal reorganization.
Harvard Medical School researchers say it is difficult to determine whether FDA expedited drug review and approval programs have actually incentivized...
FDA clears a BioCardia 510(k) for the Morph DNA deflectable guide catheter used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell...
CDRH consumer safety officer Vidya Gopal uses a Webcast to describe requirements in the production and process controls subsystem.