BRIEF—FDA seeks input on product-specific guidances to facilitate generic drug development

The US Food and Drug Administration (FDA) has published 51 product-specific guidances (47 new and four 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.

The FDA says it 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/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm.