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.

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

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 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 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 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 drugs for serious conditions that fill an unmet medical need approved based on a surrogate endpoint as defined by FDASIA Section 901 and 21 CFR 314 Subpart H;