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Vaccines, Blood & Biologics

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Section 8200: Investigational New Drugs (INDs)

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SOPP 8201: Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications
Effective Date: April 27, 1999
SOPP 8202: Handling IND Submitted with Insufficient Copies
Effective Date: March 8, 2000
SOPP 8203: Evaluation of Cost Recovery Requests for Investigational New Drugs and Investigational Device Exemptions
Effective Date: January 15, 2013
SOPP 8205: Emergency INDs
Effective Date: October 22, 2007
SOPP 8206: Discontinuing Investigational and Related Applications (IRAs)
Effective Date: March 12, 2008

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