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21 C.F.R. § 312.6

Section 312.6 - Labeling of an investigational new drug
Section 312.6 - Labeling of an investigational new drug

1 Citing brief

  1. In re: sanofi-aventis Securities Litigation

    MEMORANDUM OF LAW in Support re: 23 MOTION to Dismiss /Notice of Defendants' Motion to Dismiss the Amended Complaint, dated June 30, 2008.. Document

    Filed June 30, 2008

    Ltd.,_ U.S.___ 127 S. Ct. 2499, 2509 (2007)). 3 Case 1:07-cv-10279-GBD Document 27 Filed 06/30/2008 Page 8 of 31 September 2005) ("Drug Review Process"); 21 C.F.R. § 312.6 After the approved studies are completed, a sponsor submits a NDA, formally asking the FDA to approve the new drug for marketing. 21 U.S.C. § 355(b); Drug Review Process.