On June 29th, FDA made new recommendations on a previous draft guidance called “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” The new proposals are intended to make it easier to manufacture generic popular drugs. Some of the popular drugs that the recommendations pertain to include Sovaldi, Northera, Xtandi and Olysio. These new recommendations could make it easier for manufactures to know the testing required and the standard of bioequivalence studies that need to be performed for the generic drug.
To read more on the recommendations and new guidance, continue reading on raps.org here.