FDA warns Hong Kongs Wong Lap Kwong Medicine Company about CGMP and labeling violations in its production of finished pharmaceuticals.
Federal Register notice: FDA announces a 3/22 joint Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee meeting.
A continuing resolution that ended the government shutdown also includes a two-year suspension of the medical device excise tax.
FDA warns Italys BBCOS about CGMP violations in its manufacturing of finished pharmaceuticals.
Federal Register notice: FDA announces a timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in NDAs, ANDA...
The International Medical Devices Regulators Forum issues a proposed document to harmonize documentation and procedures used to assess whether a devic...
Eye on FDA author Mark Senak says commissioner Scott Gottlieb is issuing many more commissioner statements on various topics than his predecessor did,...
Federal Register notice: FDA extends the comment period on a draft guidance entitled The Least Burdensome Provisions: Concept and Principles.