FDA evaluation of excipients in generics
Generics may differ from their reference product in terms of inactive ingredients, e.g. excipients, provided this does not affect the safety and efficacy of the product. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by such formulation differences between generic and originator drugs [1].
Adobe Acrobat Document 104.6 KB
Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
May 2005
Pharmacology/Toxicology
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
May 2005
Pharmacology/Toxicology