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Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products: Safety Reporting Requirements forBioavailability and Bioequivalence Studies in Humans

Document ID: FDA-2000-N-0108-0071
Document Type: Rule
Agency: Food And Drug Administration
Topics: Drugs, Exports, Imports, Investigations, Labeling, Medical Research, Reporting and Recordkeeping Requirements, Safety
Federal Register Number: 2010-24296
CFR Citation: 21 CFR Parts 312 and 320
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Details Information

Document Subtype: NFR-Notice of Final Rule
Received Date: September 28 2010, at 12:00 AM Eastern Daylight Time
Start-End Page: 59935 - 59963
Page Count: 29
Comment Start Date: September 29 2010, at 12:00 AM Eastern Standard Time

Comments

   
Total: 2
Forrest Research Institute, Inc. - Comment
Posted: 01/28/2011     ID: FDA-2000-N-0108-0092

European Quality Assurance Confederation (EQAC) - Comment
Posted:     ID: FDA-2000-N-0108-0093

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