Issue Date: October 28, 2015
Issued by: Center for Drug Evaluation and Research
Topic(s): Pharmacology/Toxicology
Status: Final
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route
This guidance provides recommendations for the nonclinical evaluation of previously approved drug substances when a new formulation or a new route of administration for a previously approved formulation is proposed by the sponsor. This guidance is intended for sponsors and review staff in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) involved in the development and review of new formulations of previously approved drug substances and proposals for existing formulations to be used by a new route of administration.
Download the Guidance Document
