Guidances (Drugs) > Product-Specific Recommendations for Generic Drug Development
FDA has published 48 product-specific guidances (31 new and 17 revised) describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.
FDA always seeks feedback and considers all comments to the docket before it begins work on the final versions of product-specific guidances.
For more information and to view the guidances, visit http://www.fda.gov/drugs/
guidancecomplianceregulatoryin formation/guidances/ucm075207. htm