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GUIDANCE DOCUMENT

Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment Guidance for Industry May 2015

Draft

Not for implementation. Contains non-binding recommendations.

Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the design and conduct of nonclinical studies during development of investigational enzyme replacement therapy (ERT) products. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the substance and scope of nonclinical information needed to support initiation of clinical trials, ongoing clinical development, and marketing approval for investigational ERT products.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.