Dec 31, 2024 · CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Guidance for Industry CDER/CBER, December 2021

•CMC Requirements for INDs –Drug Substance –Drug Product •Impurities •Specifications •Stability •CMC Safety Concerns •Guidance Documents and Resources

Welcome to the "Chemistry, Manufacturing, and Controls (CMC) Perspective of the Investigational New Drug Application (IND)" Web-based training (WBT) course. This course focuses primarily on...

Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND. General CMC Requirements for INDs. Regulations; Guidance Documents; Review; D. USER INSTRUCTIONS: Click on any topic listed to jump directly to that topic, or click NEXT to continue. Click MENU to return to the course menu.

Chemistry, Manufacturing and Controls (CMC) is critical to attaining a successful registration filing and is an integral part of any pharmaceutical product application to the US Food and Drug Administration (FDA).

Sep 17, 2024 · FDA is announcing the availability of draft GFI #227 entitled “Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.” This guidance provides recommendations to sponsors submitting CMC data submissions to new animal drug applications.

Jul 16, 2024 · Navigate FDA IND process and discover how CMC sections are integral to drug development to ensure quality, safety, & potency for successful regulatory applications

FDA has issued several guidance documents that can help in the preparation of INDs. Specifically, the four guidance documents above outline CMC information that FDA recommends be submitted...

• CMC Requirements for INDs – Drug Substance – Drug Product • IND Safety Concerns • Guidance Documents and Resources

Jan 16, 2025 · As part of an effort intended to support future electronic acquisition and use of submitted information, FDA has undertaken a project to identify and prioritize pharmaceutical...