Zdrowie i gospodarka · 05/03/1997

FDA Clarifies Policy on Preapproval of Promotional Labeling for Biological Products

The FDA has clarified its policy on preapproval of promotional labeling for biological products, allowing companies to submit such information to the agency at the time of initial dissemination, eliminating the need for prior approval from the Center for Biologics Evaluation and Research (CBER).