pharmaphorum19d
Class II approval revs up Huma’s SaMD platform
Huma Therapeutics has been granted Class II clearance from the FDA ... Device (SaMD) disease management platform, dramatically expanding the range of services it can deliver. Class II approval ...
NBC Chicago1mon
How the FDA's approval for food additives works, and why experts say a loophole allows companies to bypass it
This also places ingredient safety regulations under the FDA's authority ... rigor as additives that go through the pre-market approval process.
pharmaphorum6d
ResApp bags FDA okay for sleep apnoea app, after Pfizer takeover bid
has been approved by the FDA. Brisbane, Australia-based ResApp has claimed a 510(k) clearance for SleepCheckRx as a prescription-only digital therapy in the software-as-a-medical device (SaMD ...