UPDATED August 31, 2015: The FDA has issued the final version of Guidance for Industry #227: Recommendations for Drug Sponsors Submitting Two-Phased Chemistry, Manufacturing, and Controls Technical Sections.
October 17, 2014
The U.S. Food and Drug Administration issued today draft Guidance for Industry #227: Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections, with recommendations for ways animal drug sponsors can submit chemistry, manufacturing, and controls (CMC) data to the agency to improve the efficiency of the New Animal Drug Application (NADA) review process.
GFI #227 recommends steps sponsors can take early in the animal drug development process to improve the efficiency of FDA review of the data, such as meeting with the agency prior to using the two-phased approach and completing some components of the CMC technical sections (i.e., master file references, drug substance CMC information, and analytical methods and validations) in the first phase of the process. The guidance also walks sponsors through the process for both submission phases.
The FDA is accepting public comments on this draft guidance beginning on October 20, 2014. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2014-D-1492 in the search box. Please note that the docket will not be open to accept comments until this date. The comment period will close 60 days after it publishes in the Federal Register. While comments are welcome at any time, you should submit them by the closing date for the FDA to consider your comments in drafting the final guidance.
To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-D-1492 on each page of your written comments.
The Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
- Federal Register Notice of Availability; Final Guidance for Industry: Two-Phased Chemistry, Manufacturing, and Controls Technical Sections
Federal Register Notice of Availability; Guidance: Two-Phased Chemistry, Manufacturing, and Controls Technical Sections
- Regulations.gov - Please note that the public comment period opens on October 20, 2014.
CVM GFI #227 - Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections(PDF - 105KB)
- Chemistry Manufacturing and Controls (CMC) Guidances for animal drug development