FDA commissioner Gottlieb calls for mandatory physician education on prescribing opioids for pain management and spotting opioid abuse.
Phadia U.S. recalls its ImmunoCAP Allergen c5, Ampicilloyl due to stability concerns.
Federal Register notice: FDA announces a 4/23 Science Board Advisory Committee to hear a report from CBER and the committees Research Program Review S...
FDA posts a draft guidance entitled: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.
FDA posts a draft guidance on Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.
Unfavorable results cause Incyte and Merck to stop a Phase 3 study that was evaluating Incytes epacadostat in combination with Mercks Keytruda in pati...
FDA issues complete response letters for two Celltrion biosimilars following a Warning Letter for CGMP problems at the firms Incheon, Korea, plant.
FDA commissioner Scott Gottlieb says doctors are often prescribing more opioids that patients are likely to need and more provider education and evide...