FDA opens a docket to receive feedback on exclusion of certain medical software functions from agency regulation under the 21st Century Cures Act.
FDA releases its latest batch of Warning Letters that includes Europharma Concepts, Jalco Cosmetics and Jilin Shulan Synthetic Pharmaceutical.
FDA warns Australias Jalco Cosmetics about CGMP violations in its production of finished pharmaceuticals as a contract manufacturer.
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...