Zdrowie i gospodarka · 23/08/2021

FDA Releases Revised Draft Guidance for Bioequivalence Studies Under ANDA

The FDA has released a revised draft guidance for industry on conducting bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an Abbreviated New Drug Application (ANDA). The guidance supersedes a previous version announced in 2013 and provides recommendations for applicants planning to include bioequivalence information in ANDAs and ANDA supplements.