Federal Register notice: FDA makes available a draft guidance entitled Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.
Infusion Options recalls all lots of its sterile products due to a lack of sterility assurance.
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...