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GUIDANCE DOCUMENT

Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route October 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2008-D-0142
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0142.

 
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