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Draft Guidance for Industry: Investigational New Drug Applications; Determining Whether Human Research Studies Can be Conducted Without an Invertigational New Drug Application

Document ID: FDA-2010-D-0503-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2010-25851
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Details Information

Document Subtype: GDL-Guidance
Received Date: October 13 2010, at 12:00 AM Eastern Daylight Time
Start-End Page: 63189 - 63191
Page Count: 3
Comment Start Date: October 14 2010, at 12:00 AM Eastern Standard Time
Comment Due Date: January 12 2011, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 10
Joan Cobb Pettit - Comment
Posted: 11/19/2010     ID: FDA-2010-D-0503-0004

Jan 12,2011 11:59 PM ET
Council for Responsible Nutrition (CRN) - Comment
Posted: 01/18/2011     ID: FDA-2010-D-0503-0006

Jan 12,2011 11:59 PM ET
International Scientific Association for Probiotics & Prebiotics - Comment
Posted: 01/18/2011     ID: FDA-2010-D-0503-0009

Jan 12,2011 11:59 PM ET
AstraZeneca - Comment
Posted: 01/18/2011     ID: FDA-2010-D-0503-0010

Jan 12,2011 11:59 PM ET
Merck Sharp & Dohme, Corp - Comment
Posted: 01/18/2011     ID: FDA-2010-D-0503-0011

Jan 12,2011 11:59 PM ET

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