Zdrowie i gospodarka · 05/01/2004

FDA Amends Biologics Regulations Based on Panel Recommendations

The FDA is updating its biologics regulations in response to the Panel on Review of Bacterial Vaccines and Toxoids with Standards of Potency's report, which evaluated the safety, efficacy, and labeling of bacterial vaccines and toxoids. The FDA is classifying these products into three categories: Category I (safe and effective), Category II (unsafe or ineffective), or Category IIIB (off the market pending further studies).