JD Supra1d
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 Supra22d
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 ...
BioSpace6h
Supernus Taps Potential $300M US Opportunity With FDA Win for Parkinson’s Drug-Device Combo
The FDA on Tuesday signed off on Supernus Pharmaceuticals’ apomorphine hydrochloride injection—to be marketed under the brand ...
Hosted on MSN1d
US FDA approves first-ever smart glasses with hearing aid for mild to moderate loss
In a significant advancement in hearing and vision solutions, EssilorLuxottica has announced that its Nuance Audio Glasses ...
Federal regulations paused, halting FDA's proposed ban on formaldehyde in hair products
Over the years, an increasing number of studies have linked formaldehyde to cancers that are especially prevalent among Black ...
policymed.com12d
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 ...
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 ...
US FDA Drops Web Pages on Improving Clinical Trial Diversity
CHICAGO (Reuters) - The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to ...
BioPharma Dive5d
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 Journals12d
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 ...