Federal Register notice: FDA announces support for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implem...
Medline Industries recalls certain kits, trays and packs in direct response to Nurse Assists 11/2023 recall of 0.9% sodium chloride irrigation USP and...
FDA approves Johnson & Johnsons Opsynvi, a combination single tablet of macitentan and tadalafil for treating adults with pulmonary arterial hypertens...
FDA sends Regeneron Pharmaceuticals two complete response letters on its BLA for odronextamab in relapsed/refractory follicular lymphoma and in R/R di...
Following recent Congressional action giving FDA additional authorities, the agency is again proposing a rule to ban electrical stimulation devices in...
A new Government Accountability Office report says FDA needs to evaluate its recruitment and retention efforts to support and maintain its investigato...
Federal Register notice: FDA announces a 4/12 Oncologic Drugs Advisory Committee meeting to discuss the use of minimal residual disease as an endpoint...
CDER creates a new Center of Excellence for Quantitative Medicine to advance therapeutic medical product development and inform regulatory decision-ma...
