The HHS Inspector General says FDA should educate drug dispensers about their responsibilities under the Drug Supply Chain Security Act.
Three industry stakeholders praise an FDA draft guidance on IVDs and suggest changes.
FDA approves a Hologic PMA for its Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology and their use on the companys 3Dimensio...
FDA accepts for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating certain adu...
The Government Accountability Office says that stakeholders have both positive and negative comments on FDA monitoring of the abortion drug Mifeprex a...
Federal Register notice: FDA renews for an additional two years the charter for its Gastrointestinal Drugs Advisory Committee.
FDA releases a report entitled The Voice of the Patient: Alopecia Areata that summarizes a 9/2017 public meeting that heard from patients and caregive...
Federal Register notice: FDA announces a 5/3 joint Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee meeting.