FDA's CVM Publishes New Guidances on CMC

GMP News
13 June 2007
 

FDA's CVM Publishes New Guidances on CMC

 
As reported in our GMP News of 19 June 2006, the Food & Drug Administration (FDA) had withdrawn the Guidance "Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application". By that time, the Center for Veterinary Medicines (CVM) (not CBER or CDER) was already planning to publish a revised version of an applicable guidance.

The FDA has now announced the availability of a guidance for industry entitled "Chemistry, Manufacturing, and Control Changes to an Approved NADA or ANADA." This guidance is intended to provide recommendations to holders of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) on how they should report certain changes to such applications, in accordance with the final regulation, 21 CFR 514.8, which was issued in the Federal Register of December 13, 2006 (71 FR 74766).

Together with the final guidance two related guidances were drafted:

Docket No. 2007D-0168, CDER 200766. Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations  [PDF]. Comments are due September 28, 2007.

Docket No. 2007D-0169, CDER 200520. Draft Guidance for Industry on Bioequivalence Recommendations for Specific Products [PDF]. Comments are due August 29, 2007.

Comments and suggestions regarding these guidances should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on the Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet site, select "Docket # 99D-1651 Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA" and follow the directions. All written comments should be identified with Docket No. 99D-1651.

Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
  

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