In a new draft guidance document, “New Clinical Investigation Exclusivity (3‑Year Exclusivity) for Drug Products: Questions and Answers,” FDA is stepping in to help drug sponsors prepare a request for ...

Congressmen Slam FDA’s Handling of Investigation Into Tainted Chinese Heparin Several members of the House Committee on Energy & Commerce are raising new concerns over the US Food and Drug ...

The US Food and Drug Administration (FDA) has issued new draft guidance giving drug manufacturers – for the first time – formal guidance on how the agency expects firms to respond to a Form FDA 483 ...

The Food and Drug Administration is investigating a new E. coli outbreak and has closed an investigation into another. The E. coli outbreak is linked to Raw Farm LLC’s raw milk cheddar cheese. So far ...

Senator Ron Johnson has launched an investigation into the Food and Drug Administration (FDA) over the agency’s recent denials of treatments for rare diseases, the Wisconsin Republican said in an ...

The Food and Drug Administration is investigating a new outbreak of Salmonella Newport infections. The source of the outbreak has not been determined. The FDA reports that there are seven confirmed ...