FDA Adds 67 New/Revised Product Specific Bioequivalence Guidances

“To further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.”

On October 4, 2016 FDA updated its page entitled Product-Specific Recommendations for Generic Drug Development to include the new drug guidances. Click here for charts containing links to all the new and revised Guidances.  Also included is a search feature for Bioequivalence Recommendations for Specific Products Arranged by Active Ingredient (the total is now 1,523) or contact us  for help designing your PK study.