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.
The amount and depth of CMC information that would be submitted to the Agency depends, in large part, on the phase of the investigation, the testing proposed in humans, and whether the information is safety related. This guidance identifies CMC information that would be presented in information amendments (i.e., CMC safety information) and annual reports (i.e., corroborating information).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.