FDA on pace for a Record Number of Breakthrough Devices in 2023
The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek...
Patent on Controlling Access to Drug Delisted from Orange Book
On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s...
BIOCORP Receives FDA 510(k) Clearance for Smart Injection Sensor
French medical device company BIOCORP announced in a press release that it received FDA 510(k) clearance for Mallya, a device that according to the company allows insulin pen injectors to...
