FDA releases an ICH guidance with answers to questions about its Q7 guidance on good manufacturing practices for APIs.
FDA says healthcare providers should not use the Erbe USA Erbeflo 24-hour multi-patient endoscope connector because it does not adequately mitigate ri...
FDA approves a Rigel Pharmaceuticals NDA for Tavalisse (fostamatinib disodium hexahydrate) for treating thrombocytopenia in adult patients with chroni...
FDA clears a Cantel Medical 510(k) for its Advantage Plus Pass-Thru automated endoscope reprocessor.
FDA releases an FDA-483 with 10 observations from an inspection at Coastal Meds outsourcing facility.
FDA commissioner Scott Gottlieb tells Congress that a proposed fiscal year 2019 budget increase of $663 million (13%) over last fiscal year will allow...
FDA grants fast track status to Calithera Biosciences and CB-839 in combination with cabozantinib for treating patients with metastatic renal cell car...
FDAer Leah Christl says biosimilar approvals will increase over time.