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Four drug stakeholders ask for changes to an FDA draft guidance on including adolescents in adult oncology trials.[ Price : $8.95]
FDA clears a Cianna Medical 510(k) to broaden the indication of its SCOUT reflector for use in localization of soft tissue.[ Price : $8.95]
Federal Register notice: FDA announces an 11/5 public hearing on the future format of the National Drug Code.[ Price : $8.95]
FDA posts a draft guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assiste...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Nonclinical Testing of Orally Inhaled Nicotine-Containing D...[ Price : $8.95]
FDA grants Alteogen an orphan drug designation for ALT-P7 and its use in treating gastric cancer.[ Price : $8.95]
FDA clears a Strata Skin Sciences 510(k) for its Multi-Micro Dose tip accessory for its proprietary Xtrac 308nm excimer laser.[ Price : $8.95]
FDA grants Nohla Therapeutics a fast track designation for dilanubicel (NLA101) for patients with high-risk hematologic malignanci...