jueves, 28 de enero de 2016

FDA seeks input on product-specific recommendations to facilitate generic drug development

FDA has published 47 product-specific recommendations (35 new and 12 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 BE guidances.

For more information and to view the recommendations, visit http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm 

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