Zdrowie i gospodarka · 16/03/2020

FDA Announces Final Guidance for Competitive Generic Therapies

The Food and Drug Administration (FDA) has released a final guidance document outlining the process for requesting designation of a drug as a competitive generic therapy (CGT) and the criteria for designating a drug as a CGT, as well as expedited review procedures for abbreviated new drug applications (ANDAs) for CGT-designated drugs.