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21 C.F.R. § 314.100

Section 314.100 - Timeframes for reviewing applications and abbreviated applications
Section 314.100 - Timeframes for reviewing applications and abbreviated applications

3 Citing briefs

  1. Rahn v. Genzyme Corporation et al

    MEMORANDUM in Support re MOTION to Dismiss Consolidated Class Action Complaint

    Filed June 2, 2010

    L. 110-85, § 101(c), Sept. 27. 2007; Letter from Michael O. Leavitt, Secretary of Health and Human Services, to the Honorable John D. Dingell, Chairman, House Committee on Energy and Commerce, Section A: PDUFA IV Reauthorization Performance Goals and Procedures: Fiscal Years 2008 through 2012 (Sept. 27, 2007), available at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm.; 21 C.F.R. § 314.100(a), (c) (2009); Henry Grabowski et al., Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act, 51 J.L. & Econ.

  2. 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

    160 .................................................................................. 6 21 C.F.R. 14.171 .................................................................................. 6 21 C.F.R. §312.................................................................................... 4 21 C.F.R. § 314.100............................................................................... 4 21 C.F.R. § 314. 101............................................................................... 4 21 C.F.R. § 314.

  3. Fishbury, Limited et al v. Connetics Corporation et al

    MOTION to Dismiss 86 Plaintiff's Second Amended Consolidated Class Action Complaint

    Filed May 2, 2008

    852 ........................................................................................................................ 6 21 C.F.R. § 314.1 ............................................................................................................................ 5 21 C.F.R. § 314.100 ........................................................................................................................ 5 21 C.F.R. § 314.102 .................................................................................................................... 5, 6 21 C.F.R. § 314.