INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information: Guidance for Industry

Description

This guidance provides recommendations to sponsors of investigational new drug applications (INDs) on the chemistry, manufacturing, and controls (CMC) information that would be submitted for phase 2 and phase 3 studies conducted under INDs.  This document applies to human drugs (as defined in the Federal Food, Drug, and Cosmetic Act).  The guidance does not apply to botanical drug products, protein drug products derived from natural sources or produced by the use of biotechnology, or other biologics. The goals of the guidance are to (1) ensure that sufficient data will be submitted to the Agency to assess the safety, as well as the quality of the proposed clinical studies from the CMC perspective, (2) expedite the entry of new drug products into the marketplace by clarifying the type, extent, and reporting of CMC information for phase 2 and phase 3 studies, and (3) facilitate drug discovery and development.

Scope & Applicability

Regulatory Context

• 21CFR312.22§ 312.22 General principles of the IND submission.

  (a) FDA's primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phase 2 and 3, to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug's effectiveness and safeRead full regulation →

• 21CFR312.23§ 312.23 IND content and format.

  (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →

• 21CFR312.31§ 312.31 Information amendments.

  (a) Requirement for information amendment. A sponsor shall report in an information amendment essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report. Examples of information requiring an information amendment include:Read full regulation →

• 21CFR312.33§ 312.33 Annual reports.

  A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes:Read full regulation →

• Clinical Investigator (Sponsor)

  Angela D. Ritter, M.D.

  2024-06-18

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