Medical Device and Diagnostic Industry (MD+DI)

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

FDA will consider easing restrictions on peptides as RFK Jr. calls himself a "big fan"

The FDA meeting announcement​ follows repeated pledges by Health Secretary Robert F. Kennedy Jr. to loosen regulations on ...
Medical Device and Diagnostic Industry (MD+DI)

User Fees Drive Most of the CDRH Increase in FDA’s Budget Request

FDA has released its budget request for fiscal year 2027, which would provide the agency’s Center for Devices and ...
Regulatory Affairs Professionals Society

FDA warns firm for inappropriate use of AI in drug manufacturing

The US Food and Drug Administration (FDA) has issued a warning letter to Purolea Cosmetics Lab for several violations of Good ...
WVEC

New COVID vaccine regulations create more barriers for Virginians looking to get vaccinated

NORFOLK, Va. — You used to be able to easily walk into your local pharmacy and get a COVID-19 vaccine, but with new FDA regulations, it might not be as simple in the future. The next round of COVID-19 ...
Yahoo

FDA could relax regulations on dietary supplements and it could have a big impact on your health

The U.S. Food and Drug Administration is moving toward a controversial change in how warning labels appear on dietary supplements, which would reduce how often key disclaimers must be displayed on ...
BioSpace

FDA flexibility isn’t absent but evolving regulations come with growing pains

The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare ...
RAPS

Trump Pledges to Gut FDA: Which Regulations Need to Go?

With an executive order (EO) and comments from President Donald Trump yesterday calling for a massive overhaul of US Food and Drug Administration (FDA) regulations, legal experts and former FDA ...