FDA warns a Web site operating at chloroquineonline.com that it is selling unapproved and misbranded drug products claiming to prevent, mitigate, or t...
FDA clears a Sekisui Diagnostics 510(k) for the Osom Ultra Plus Flu A&B Test.
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...