The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Waivers for Bioavailability and Bioequivalence Studies

    The US Food and Drug Administration (FDA) on Friday finalized guidance for sponsors who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirements for immediate release (IR) solid oral dosage forms based on an approach termed the Biopharmaceutics Classification System (BCS). The guidance, finalized from a 2015 draft, explains what is necessary for sponsors of investigational new drugs (INDs) and applicants of new drug ...