FDA Bioavailability Guidance needs changes: Drugmakers


The FDA's draft guidance on the Bioavailability (BA) is yet again in demand for changes by the drug makers and the industry groups. The guidance is 27 paged and will effectively replace the 2014 guidance on Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs – General Considerations, once it is finalized.

Further, changes concerning Pharmacokinetic (PK) and Pharmacodynamics (PD) modeling and Bioanalytical methodologies were suggested. BA/bioequivalence waivers, food effects drafts by FDA, and batch size for pivotal BE studies are other areas which have been suggested to bring about changes by the PhRMA.