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].

More

Download
FDA evaluation of excipients in generics
Adobe Acrobat Document 104.6 KB
Download
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
UCM079250.pdf
Adobe Acrobat Document 229.5 KB