Zdrowie i gospodarka · 07/10/1997

Expedited Safety Reporting Requirements for Human Drug and Biological Products

The Food and Drug Administration (FDA) is updating its expedited safety reporting regulations for human drugs and biological products to align with the International Conference on Harmonisation 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. The changes aim to standardize postmarketing safety monitoring and reporting procedures for pharmaceutical companies.