Module 12 2019

Legal Basis - Requirements for Submission of Animal Toxicity Data

INDs: 21 CFR 312.23(a)(8)(ii)(b) ● The sponsor should submit, for each animal toxicology study that is intended to support the safety of the proposed clinical investigation, a full tabulation of data suitable for detailed review. NDAs: 21 CFR 314.50 (d) ● The application is required to contain the technical sections described below. Each technical section is required to contain data and information in sufficient detail to permit the agency to make a knowledgeable judgment about whether to approve the application or whether grounds exist under section 505(d) of the act to refuse to approve the application.

The Organisation for Professionals in Regulatory Affairs

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