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

The FDA Friday issued a draft guidance to clarify what establishments and types of food are covered by the menu labeling rule, how to determine calorie counts, and how and where calorie counts should ...

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 ...

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, ...

On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: ...

The FDA is raising efficacy questions over Lundbeck and Otsuka’s proposed combination of their Rexulti with Viatris’ Zoloft as a treatment for post-traumatic stress disorder (PTSD). For an upcoming ...

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 ...

Republican senators on Wednesday urged the Food and Drug Administration (FDA) to tighten safety standards and reconsider partnerships tied to abortion pills, accusing the agency of expanding access ...