Module 12 Presentations

26/01/2024

FDA Use of Data Standards “Catalog”

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog

The Organisation for Professionals in Regulatory Affairs

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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.  Standard for the Exchange of Nonclinical Data (SEND)

The Organisation for Professionals in Regulatory Affairs .

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