Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization

FDA is issuing (Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization) guidance to provide recommendations to sponsors on the development of…

Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products

Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products guidance provides considerations for sponsors proposing to design a new registry or…

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data…

Rare Diseases: Considerations for the Development of Drugs and Biological Products

Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

Draft Guidance on drug development Citalopram Hydrobromide