FDA warns Chinas Jilin Shulan Synthetic Pharmaceutical Co. about CGMP deviations in its production of active pharmaceutical ingredients.
FDA accepts for priority review an Astellas Pharma NDA for gilteritinib for treating adult patients who have relapsed or refractory acute myeloid leuk...
FDA clarifies the submission process for expedited serious adverse event reports arising from ANDA BA/BE premarket studies.
FDA grants Pfizer a Breakthrough Therapy designation for Xalkori (crizotinib) for treating patients with metastatic non-small cell lung cancer who hav...
FDA clears a Lumendi 510(k) for the DiLumen Is Endolumenal Interventional Scissors, a sterile, single-use, disposable, monopolar electrosurgical devic...
FDA warns Irelands Europharma Concepts about CGMP violations in its production of finished pharmaceuticals as a contract manufacturer.
Two Ropes & Gray attorneys highlight things learned from an FDA draft guidance on how FDA will regulate multiple function medical devices.
FDA reminds healthcare professionals working in surgical settings of the risk of surgical fires that can injure patients.