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

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 ...

On November 29, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements. First, FDA issued a draft guidance titled Questions and Answers ...

On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: ...

With 99% of patients experiencing an adverse event, the FDA is skeptical that the risks associated with Geron’s myelodysplastic syndromes (MDS) medicine imetelstat outweigh the potential benefit of ...

With states like California, Illinois, and New York questioning the safety of certain food additives and some other chemicals used in food, the public is wondering if a food is safe to eat if it ...

President Donald Trump’s pick to lead the Food and Drug Administration is set to answer Senate questions Thursday about his plans for the agency, which may soon be at the center of an administration ...