JD Supra1d
From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
Hosted on MSN1d
RFK Jr.’s New Role Will Likely Change 6 Longstanding FDA Practices, Says National Expert
A seasoned FDA compliance and regulations expert says you can watch for these major ways health intelligence may change for ...
FDA’s plan to propose ban on formaldehyde in hair-straightening products remains in limbo under Trump administration
A plan for the US Food and Drug Administration to propose banning formaldehyde and certain formaldehyde-releasing chemicals ...
Food3d
What does FDA’s freeze mean for the food industry?
While a pause on federal health agencies is nothing new during presidential transitions, the Trump Administration’s ...
STAT1d
The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia
If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...
JD Supra2d
FDA Publishes Rule Updating ‘Healthy’ Nutrient Content Claim
On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food ...
STAT9d
FDA clinical trial inclusivity guidelines will be back
and served on the FDA Drug Safety and Risk Management Advisory Committee from 2017 to 2024. These guidelines were established under the Food and Drug Omnibus Reform Act of 2022, enacted by ...
medtechdive3d
Former FDA head Gottlieb calls for less regulation of certain AI tools
Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st ...