Federal Register notice: FDA announces a 9/17 public hearing entitled Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeut...
Federal Register notice: FDA submits to OMB an information collection extension for Substances Generally Recognized as Safe (GRAS): Notification Proce...
Federal Register notice: FDA amends a 5/6 Federal Register notice about a 6/20 meeting of the Oncologic Drugs Advisory Committees Pediatric Oncology S...
FDA issues new guidance and schedules a public meeting on its benefit/risk assessment framework for opioid analgesics.
FDA accepts for priority review a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) to expand the current indication to include adult p...
FDA accepts for priority review an Alexion Pharmacuticals supplemental BLA for Ultomiris (ravulizumab-cwvz), the companys long-acting C5 complement in...
Sen. Chuck Grassley says he opposes a Trump administration proposal to tie prices Medicare pays for some drugs to the lower prices paid in other count...
CDERs Office of Prescription Drug Promotion solicits comments on two proposed research studies on comprehension of oncology indications in TV ads.