Regulacje i polityka gospodarcza · 27/10/1994

FDA Proposes Changes to Adverse Experience Reporting Regulations for Human Drug and Licensed Biological Products

The Food and Drug Administration (FDA) is proposing to update its adverse experience reporting regulations for human drug products and licensed biological products to align with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the World Health Organization's Council for International Organizations of Medical Sciences (CIOMS) recommendations, aiming to simplify and standardize the reporting of adverse experiences.