Zdrowie i gospodarka · 15/04/2022

FDA Announces Final Guidance on Bioavailability Studies for NDAs and INDs

The US Food and Drug Administration (FDA) has released a final guidance document outlining general considerations for bioavailability studies submitted in Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and NDA supplements, replacing a previous draft guidance issued in 2014 and finalizing a 2019 draft.