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.

  • Another FDA guidance for industry, Special Protocol Assessment (SPA), explains that the SPA process can be used for clinical trials that will form the basis of an efficacy claim in an NDA or BLA.

  • The XRX-OXY-302 Clinical Trial is planned to start in the second half of 2024, subject to Special Protocol Assessment review by FDA.

  • The 27 See Federal Food, Drug, and Cosmetic Act, Section 505(b)(5)(B) and (C); Guidance for Industry: Special Protocol Assessment (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM080571.pdf).

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

  • In September 2015, the FDA issued a Special Protocol Assessment, or SPA, for our Phase 3 PAH program for INOpulse, which will include two confirmatory clinical trials, undertaken either sequentially or in parallel.

  • After discussions between the FDA and Astellas, a confirmatory Phase 3 clinical trial (“ACT 5”) was initiated in October 2009 under a Special Protocol Assessment.

  • 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.

  • Special Protocol Assessment The FDA and an IND sponsor may agree in writing on the design and size of clinical studies intended to form the primary basis of a claim of effectiveness in an NDA.

  • Early this year, we set the stage for our Phase III trial of neratinib in patients with third-line metastatic HER2-positive breast cancer when we reached agreement on a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA).


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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Related to Special Protocol Assessment

  • Data Protection Impact Assessment means an assessment by the Controller of the impact of the envisaged processing on the protection of Personal Data.

  • Medical assessment means an assessment of a patient’s medical condition secured by our Assistance Company working in conjunction with the Medical Evacuation Provider’s medical director and in collaboration with the attending physician. The Assistance Company in collaboration with the Medical Evacuation Provider, will utilize the assessment to determine at its sole discretion whether a Plan Holder is fit to fly; the most appropriate means to provide medical evacuation; the medical personnel who will be accompanying the patient on the transport; and to confirm the medical facility closest to one’s home can meet their medical needs. If the patient’s medical facility of choice is unable to provide the high level of medical care required by the patient, arrangements will be made to transport the patient to the appropriate medical facility closest to their home, or closest to patient's preferred medical facility in the US when possible.

  • Special Assessment means any assessment levied against a unit owner other than the assessment required by a budget adopted annually.

  • Initial assessment means an assessment conducted prior to or at admission to determine whether the individual meets the service's admission criteria; what the individual's immediate service, health, and safety needs are; and whether the provider has the capability and staffing to provide the needed services.

  • Regulatory Flood Protection Elevation means the “Base Flood Elevation” plus the “Freeboard”. In “Special Flood Hazard Areas” where Base Flood Elevations (BFEs) have been determined, this elevation shall be the BFE plus two (2) feet of freeboard. In “Special Flood Hazard Areas” where no BFE has been established, this elevation shall be at least two (2) feet above the highest adjacent grade.

  • Phase I assessment as described in, and meeting the criteria of, (i) Chapter 5 of the FNMA Multifamily Guide or any successor provisions covering the same subject matter in the case of a Specially Serviced Mortgage Loan as to which the related Mortgaged Property is multifamily property or (ii) the American Society for Testing and Materials in the case of Specially Serviced Mortgage Loan as to which the related Mortgaged Property is not multifamily property.

  • Flood Insurance Regulations means (i) the National Flood Insurance Act of 1968 as now or hereafter in effect or any successor statute thereto, (ii) the Flood Disaster Protection Act of 1973 as now or hereafter in effect or any successor statue thereto, (iii) the National Flood Insurance Reform Act of 1994 (amending 42 USC 4001, et seq.), as the same may be amended or recodified from time to time, and (iv) the Flood Insurance Reform Act of 2004 and any regulations promulgated thereunder.

  • Flood Insurance Study (FIS means an examination, evaluation, and determination of flood hazards, corresponding water surface elevations (if appropriate), flood hazard risk zones, and other flood data in a community issued by the FEMA. The Flood Insurance Study report includes Flood Insurance Rate Maps (FIRMs) and Flood Boundary and Floodway Maps (FBFMs), if published.

  • Impact Assessment has the meaning given to it in Clause 22.1.3 (Variation Procedure);

  • Assessment of Compliance As defined in Section 3.21.

  • Flood Insurance Study means the official report provided by the Federal Insurance Administration that includes flood profiles, the Flood Insurance Rate Map, the Flood Boundary and Floodway Map, and the water surface elevation of the base flood.

  • Risk assessment means a programme to determine any risk associated with any hazard at a construction site , in order to identify the steps needed to be taken to remove, reduce or control such hazard;

  • Environmental Assessment Act means the Environmental Assessment Act, R.S.O. 1990, c.E.18.

  • Commercial project means any project, including, but not

  • Comprehensive assessment means the gathering of relevant social, psychological, medical and level of care information by the case manager and is used as a basis for the development of the consumer service plan.

  • Acoustic Assessment Report means the report, prepared in accordance with Publication NPC-233 and Appendix A of the Basic Comprehensive User Guide,by HGC Engineering and dated August 22, 2008 submitted in support of the application, that documents all sources of noise emissions and Noise Control Measures present at the Facility and includes all up-dated Acoustic Assessment Reports as required by the Documentation Requirements conditions of this Certificate to demonstrate continued compliance with the Performance Limits following the implementation of any Modification.

  • Sustainability Report means the annual non-financial disclosure form according to the GRI Standard for Sustainability Reporting publicly reported by the Borrower and published on an Internet or intranet website to which each Lender and the Administrative Agent has or has been granted access free of charge.

  • Creation Application means an application by a Participating Dealer for the creation and issue of Units in an Application Unit size (or whole multiples thereof) in accordance with the Operating Guidelines and the Trust Deed.

  • Cathodic protection tester means a person who can demonstrate an understanding of the principles and measurements of all common types of cathodic protection systems as applied to buried or submerged metal piping and tank systems. At a minimum, such persons must have education and experience in soil resistivity, stray current, structure-to-soil potential, and component electrical isolation measurements of buried metal piping and tank systems.

  • Progress Assessment Report (PAR means the monthly compliance report to Owner verifying compliance with the HUB subcontracting plan (HSP).

  • Phase I Environmental Assessment A “Phase I assessment” as described in, and meeting the criteria of, the ASTM, plus a radon and asbestos inspection.

  • Assessment Report : means the assessment report referred to in Articles 32(2) and 33(3) of Regulation (EC) No 834/2007 drawn up by an independent third party fulfilling the requirements of ISO Standard 17011 or by a relevant competent authority, which includes information on document reviews, including the descriptions referred to in Articles 4(3)(b) and 11(3)(b) of this Regulation, on office audits, including critical locations and on risk-oriented witness audits conducted in representative third countries.

  • Functional behavioral assessment means an individualized assessment of the student that results in a team hypothesis about the function of a student’s behavior and, as appropriate, recommendations for a behavior intervention plan.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Closing protection letter means an agreement by the division to indemnify a lender or owner or both for loss caused by a division closer’s theft of settlement funds or failure to comply with written closing instructions relating to title certificate coverage when agreed to by the division closer.

  • Independent educational evaluation means an evaluation conducted by a qualified examiner who is not employed by the public agency responsible for the education of the child in question.