Federal Register notice: FDA seeks comments on an information collection extension for Information To Accompany Humanitarian Device Exemption Applicat...
Federal Register notice: FDA seeks comments on an information collection extension for Evaluation of the Program for Enhanced Review Transparency and ...
FDA warns Hospira Healthcare India about CGMP violations in its production of finished pharmaceuticals.
HHS secretary Alex M. Azar III appoints National Cancer Institute director Norman E. Sharpless to serve as acting FDA commissioner after Scott Gottlie...
Two stakeholders make suggestions for revising the FDA software precertification working model.
The Justice Department says Covidien is paying more than $17 million in settle False Claims Act whistleblower allegations that it illegally provided s...
FDA releases its latest batch of Warning Letters that include Anicare Pharmaceutical, Jubilant Life Sciences, Laboratorios Quantium and Pfizer (Hospir...
FDA approves an Alkem Laboratories ANDA for a new generic of Diovan (valsartan), an angiotensin II receptor blocker that treats high blood pressure an...