Zdrowie i gospodarka · 08/12/1995

FDA Introduces Interim Definition and Eliminates Lot-by-Lot Release for Certain Biotechnology Products

The FDA is issuing an interim definition for well-characterized therapeutic recombinant DNA-derived and monoclonal antibody biotechnology products, and eliminating the need for lot-by-lot release for these products, in an effort to reduce industry burdens while maintaining public health protection.