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GUIDANCE DOCUMENT

S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals December 2009

Final

S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals


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.