The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...
This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
Less than two weeks after rejecting Sanofi’s investigational multiple sclerosis drug, the FDA has publicly shared the ...
Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact ...
The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental ...
Alzheimer’s disease is a devastating condition that affects more than 7 million Americans, according to the Alzheimer’s Association. As the Baby Boomer generation ages, this number is estimated to ...