us-fda-guidance-2164219e81b5dcab9816cdd5a4b3f5e5•Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry
Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry
us-fda-guidance-2164219e81b5dcab9816cdd5a4b3f5e5Preparation of Investigational New Drug Products (Human and Animal): Guidance for IndustryGuidance
Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.
Guideline of the preparation of investigational new drug products (human and animal).
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:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.
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