Hogan Lovells attorneys highlight the provisions in an updated compliance manual for CDER- and CDRH-led combination products.
Researchers from FDA and drug companies summarize FDAs acceptance of real-world data in drug approvals.
Natural Products Insider says FDA has sent a CBD guidance document to the Office of Management and Budget for review.
Academic researchers find some progress made in sex-inclusive scientific studies but more needs to be accomplished.
FDA releases its latest batch of Warning Letters that includes one medical product company chloroquineonline.com.
FDA walks back misleading testimony by CDER deputy director Douglas Throckmorton who testified at a Senate Finance committee last week that the U.S. i...
Americans for Homeopathy Choice Foundation asks FDA to adopt a regulation specifying requirements for homeopathic drugs and determining that such drug...
Senators Mike Braun (R-IN), Lisa Murkowski (R-AK), and Martha McSally (R-AZ) introduce the Promising Pathway Act (S. 3872) that would establish a roll...