Issue Date: September 17, 2024
Issued by: Center for Veterinary Medicine
Topic(s): Premarket, Animal Drugs, Chemistry, Manufacturing, and Controls (CMC), Investigational New Animal Drug (INAD), New Animal Drug Application (NADA)
Status: Draft
CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies
This guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. There are several mechanisms to receive input from the Center for Veterinary Medicine (CVM) prior to submission of the CMC technical section, as well as various approaches to submitting the CMC technical section itself. For review efficiency, CVM prefers that full CMC information be provided in a single technical section submission. However, there may be instances when submission of the individual components of the technical section (drug product, drug substance, and facility sterile process validation (SPV) information for sterile drug products) could reduce the overall time to complete a technical section, and therefore drug approval. This guidance describes the options for soliciting early input from CVM and the process for submission of components of the CMC technical section.
Download the Guidance Document
