JD Supra3d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
JD Supra24d
FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
FDA Medical Device Regulation Over the Use of AI in Clinical Trials As FDA noted in the JAMA article, artificial intelligence and machine learning (AI/ML) have many potential uses in clinical ...
dvm36020h
FDA notifies veterinarians of animal burn risk linked to human medical devices
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
GlobalData on MSN9d
Six months “a very limited window” for medical device shortage flagging
Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...
Hosted on MSN18h
Supernus wins FDA approval for Parkinson’s pump on fourth try
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
FDA bans Red No. 3, but experts warn of ongoing gaps in food safety regulations
The Food and Drug Administration announced last week that it will revoke authorization for FD&C Red No. 3 in food and ...
policymed.com14d
Final FDA SIUU Guidance: Understanding the Key Updates and Resources
In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...
STAT29d
FDA pushes makers of AI devices to disclose more details on testing, performance
The Food and Drug Administration wants the developers of medical devices that rely on artificial intelligence to disclose much more detail about how their devices were developed and tested ...
BioPharma Dive7d
Troy Tazbaz, an FDA digital health leader, resigns
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...
The Business Journals14d
Liberty human tissue bank sues FDA over regulation of umbilical cord product
Vitti Labs says the Food and Drug Administration erred in subjecting the lab's umbilical cord-derived product in a way that brings greater regulation. Liberty-based Vitti Labs, a human tissue bank ...