FDA grants Berg an orphan drug designation for its leading product candidate BPM31510, indicated for treating pancreatic cancer.
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,...