The CDER Quantitative Medicine Center of Excellence posts four new resources.
Federal Register notice: FDA set biosimilar user fee rates for fiscal year 2025.
Federal Register notice: FDA posts the over-the-counter monograph order request fee rates for fiscal year 2025.
Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for Quantitative Testing for the Develop...
CDER explains how it used artificial intelligence/machine learning (AI/ML) to help identify the patient population most likely to benefit from Sobis K...
FDA grants Zymedi an orphan drug designation for ZMA001, a monoclonal antibody in development for pulmonary arterial hypertension.
FDA and Health Canada issue a notice alerting healthcare providers and facilities about the safe use of Megadyne Medical Products Mega 2000 and Mega S...
Researchers from FDA and other entities recommend ways to improve the collection and analysis of overall survival (OS) data in cancer drug trials.
