The US Food and Drug Administration (FDA) on Thursday published revised draft product-specific guidances (PSGs) for immediate-release solid oral generic drugs deemed to be low risk that will no longer require two bioequivalence (BE) studies – one fed and one fasting – to demonstrate BE to a reference-listed drug. Instead, sponsors can choose to conduct either a fed or fasting bioequivalence study for the affected drugs.
The action aligns with the International Council for Harmonisation’s (ICH) M13A guideline, which was adopted in August 2024 and issued as final guidance by FDA this week. (RELATED: ICH adopts M13A guideline on bioequivalence testing, Regulatory Focus 6 August 2024)
FDA said in a notice accompanying the guidance that the document “aims to increase the efficiency of drug development and accelerate the availability of safe and effective orally administered immediate-release solid oral dosage forms.” FDA is issuing the PSGs that have been affected by ICH M14 in batches…
