FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

WASHINGTON (AP) — Federal health regulators have questions about the benefits of an experimental combination drug for cystic fibrosis, including whether the addition of a second drug ingredient adds ...

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...

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 ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Helen Branswell covers issues ...

President Donald Trump’s pick to lead the Food and Drug Administration largely sidestepped questions Thursday from senators about how he would handle numerous pressing issues before the agency, ...

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 ...

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. President Donald Trump’s pick to lead the ...