Special Protocol Assessment definition

Special Protocol Assessment means the procedures adopted by the United States Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research for evaluating issues related to the adequacy of certain proposed studies associated with the development of products in human drug applications as defined in section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) for products covered by the Prescription Drug User Fee Act of 1992, as further described in section 119(a) of the Food and Drug Administration Modernization Act.
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Special Protocol Assessment means an FDA review of, and written agreement with, a study sponsor regarding the proposed clinical protocols for one or more Phase III Trials whose data will form the primary basis for an efficacy claim for drug product as further described in the FDA Guidance for Industry, Special Protocol Assessments (May 2002).
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Special Protocol Assessment means an agreement between FDA and a sponsor, as described in Section 505(b)(5) of the FDCA and related FDA guidance documents, whereby FDA agrees that the design, endpoints, and planned analyses of a clinical trial is adequate to provide the necessary data to support a BLA Filing.
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Examples of Special Protocol Assessment in a sentence

  • The study is conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration.

  • Unless otherwise determined by the ▇▇▇▇▇ Indication Committee, at each of the Special Protocol Assessment Meeting and the Pre-NDA Meeting for the ▇▇▇▇▇ Indication, ▇▇▇▇▇ may have one representative present who may attend only as an observer.

  • The Seller (or its Permitted Licensee) shall conduct the ASCENT Trial in accordance the Special Protocol Assessment between the Seller and the FDA for such trial, as such Special Protocol Assessment may be amended from time to time.

  • The study was conducted in accordance with a Special Protocol Assessment (SPA) with the FDA.

  • The clinical program includes a two part pivotal Phase 3 program conducted under Special Protocol Assessment with the FDA, a 12-month Phase 2 trial and a 48-hour Phase 1 onset-of-action trial.

  • Taliglucerase alfa is an enzyme replacement therapy in development under a Special Protocol Assessment with FDA for Gaucher’s disease.

  • Following a Special Protocol Assessment by the FDA, two Phase III trials of retigabine were initiated in 2005.

  • In March 2011, Allos reached agreement with the FDA under its Special Protocol Assessment (SPA) process for the design of Allos' Phase 3 clinical trial of FOLOTYN in patients with previously undiagnosed PTCL.

  • Lupuzor™ was given a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) to conduct Phase III trials with Fast Track Designation.

  • Ofranergene obadenovec is currently being studied in a Phase 3 pivotal trial for rGBM, conducted under an FDA Special Protocol Assessment (SPA).


More Definitions of Special Protocol Assessment

Special Protocol Assessment means the special protocol assessment granted by the FDA for the PRESENT Trial as in effect on the Original Issue Date.
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Special Protocol Assessment means the request for special protocol assessment for the Phase 2 PoC Trial which was submitted by Isis to FDA.
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