FDA has published 48 product-specific recommendations (44 new and 4 revised) describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.
FDA is always seeking feedback and considers all comments to the docket before it begins work on the final version of the BE guidance.
For more information and to view the recommendations, visit http://www.fda.gov/drugs/
guidancecomplianceregulatoryin formation/guidances/ucm075207. htm