The FDA staff’s view clashes with RFK Jr.’s push to deregulate peptides and move more of them toward Category 1 status.
During the second meeting of the US Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC), members of the panel seemed shocked and, at times, lost for words when grappling with ...
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 ...