Accelerated Approval definition

Accelerated Approval means FDA approval of a BLA that (a) includes clinical data from a Phase 2 Trial or Phase 2/3 Trial, but no clinical data from a Phase 3 Trial; (b) has been granted expedited review by the FDA (e.g., such BLA has been granted a Breakthrough Therapy designation pursuant to Section 506(a) of the FFDCA or a Fast Track designation pursuant to Section 506(b) of the FFDCA); or (c) has been granted orphan drug status pursuant to Section 526 of the FFDCA.

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Accelerated Approval means United States Regulatory Approval obtained pursuant to the FDA’s Accelerated Approval Program as set forth in 21 C.F.R. § 601 Subpart E or 21 C.F.R. § 601 Subpart H (as applicable) or any successor program.

Accelerated Approval means approval for Marketing Authorisation of the Licensed Product in the United States of America on the basis of an application made to the FDA pursuant to the Code of Federal Regulations, Title 21, Part 314 (subpart H - accelerated approval of new drugs for serious or life threatening illnesses) or its equivalent in any jurisdiction;

Examples of Accelerated Approval in a sentence

• These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as FDA guidance on an efficient drug development program.

• The Company and its Affiliates and Licensees are in material compliance with the requirements and conditions of all Regulatory Approvals, including any requirements to conduct confirmatory studies as part of an Accelerated Approval pursuant to 21 U.S.C. § 356(c), as such requirements and conditions may have been amended by a Regulatory Agency or comparable authority.

• Advanced development/pivotal studies—Includes 1) expanded human safety studies, 2) animal efficacy studies if following the Animal Rule or clinical studies required for Accelerated Approval; and 3) other studies as deemed necessary by FDA for approval or licensure of product.

• The Contractor shall develop and submit plans to conduct advanced development/pivotal studies including 1) expanded human safety studies, 2) animal efficacy studies (in appropriate models of inhalational anthrax disease if following the Animal Rule) or clinical studies required for Accelerated Approval using validated endpoints; and 3) other studies as deemed necessary by FDA.

• The Contractor shall initiate and complete advanced development/pivotal studies including 1) expanded human safety studies, 2) animal efficacy studies (in appropriate models of inhalational anthrax disease) if following the Animal Rule, or clinical studies required for Accelerated Approval, and 3) other studies as deemed necessary by FDA.

More Definitions of Accelerated Approval

Accelerated Approval means the FDA drug approval process defined in 21 U.S.C. §356(c)(1)(A).

Accelerated Approval means the granting of Regulatory Approval by FDA based on a surrogate endpoint or intermediate clinical endpoint, as permitted by applicable FDA rules, orders and guidances.

Accelerated Approval means any drug approved under the FDA Accelerated Approval Program which still need to be tested after approval in clinical trials using endpoints that demonstrate clinical benefit.

Accelerated Approval has the meaning set forth in Section 1.102.

Accelerated Approval means approval of a Product NDA pursuant to 21 C.F.R. Part 314 Subpart H (a) in which the FDA evaluation of the NDA is performed on the basis of a surrogate marker (a measurement intended to be a substitute for the clinical measurement of interest) that is considered likely to predict patient benefit and (b) that may be a provisional approval, with a required written commitment to complete clinical studies that formally demonstrate patient benefit.

Accelerated Approval means an initial marketing approval for a product by the FDA pursuant to 21 U.S.C. 356(c) or 21 CFR Part 314, Subpart H based upon a surrogate endpoint or an intermediate clinical endpoint.

Accelerated Approval means a drug candidate approved under FDA’s accelerated approval pathway (Section 506(c) of the FD&C Act) (or foreign equivalent). “Accounting Standards” means the International Financial Reporting Standards (“IFRS”), the U.S. Generally Accepted Accounting Principles (“U.S. GAAP”), and any other internationally recognized accounting standards. “Acquiror” has the meaning set forth in Section 14.4. “Affiliate” means any individual, corporation, association or other business entity that directly or indirectly controls, is controlled by, or is under common control with the Party in question. As used in the definitions of “Affiliate,” “BP Parent Entity” and “BP Restricted Entities” only, the term “control” means the direct or indirect ownership of more than fifty percent (>50%) of the stock having the right to vote for directors thereof or the ability to otherwise control the management of the corporation or other business entity whether through the ownership of voting securities, by contract, resolution, regulation or otherwise. “Agreement” means this document including any and all exhibits and amendments to it as may be added and/or amended from time to time in accordance with the provisions of this Agreement. “Alliance Manager” has the meaning set forth in Section 3.1. “Antibody” means any monoclonal or polyclonal antibody, whether multiple or single chain, recombinant or naturally occurring, whole or fragment, and any variants, derivatives or constructs thereof, including but not limited to, antigen binding portions including Fab, Fab’, F(ab’)2, Fv, dAb and CDR fragments, single chain antibodies (scFv), chimeric antibodies, diabodies and polypeptides (including any humanized versions thereof) that contain at least a portion of an immunoglobulin that is sufficient to bind selectively to a specific antigen, including a Target. For the avoidance of doubt, an Antibody Building Block is an Antibody. “Antibody Building Block” means the Antibody used in a Product. “Anticalin” or “Anticalin protein” means, (a) any lipocalin mutein isolated from the Anticalin Libraries, or (b) any lipocalin mutein that, in each case, has been derived (either physically, intellectually or by reverse engineering, in one (1) or more steps) from any lipocalin mutein referred to in Section (a) of this definition, in each case, which binds and