FDA-CVM Guidance

FDA/CVM Guidance for Industry 144—Pre-Approval Information for Registration of New Veterinary Medicinal... 

FDA/CVM Guidance for Industry ( 3), General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals. Revised July 1994 http // www.fda.gov/cvm/guidance/guideline3toc.html (accessed... 

FDA/CVM Guidance for Industry ( 144), Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance VICH GL27. Finalized 04-27-04 http //www.fda.gov/cvm/guidance/guidel44. doc (accessed 08-02-04). 

FDA/CVM Guidance for Industry FDA Approval of New Animal Drugs for Minor Uses and for Minor Species. Finalized 01/1999 http //www.fda.gov/cvm/ guidance/minorgde.pdf (accessed 08-26-04). 

The long-term stability of an oral liquid formulation can also be affected by a number of unexpected reasons. Contamination by solvents used during the tank cleaning or even in the manufacture of excipients or API can be a source of instability of an oral solution. Uncontrolled levels of Class I, II, or III solvents could lead to the rejection of a batch or an excipient vendor. Class III solvents have a permitted daily exposure of 50 mg or less per day. (See the International Conferences on Harmonization, Impurities Guidelines for Residual Solvents. Q3C, Federal Register 1997 62(247) 67377 and also http //www.fda.gov/cvm/Guidance/guidelOO.PDF). 

FDA CDER, CBER, CVM. Guidance for Industry—Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (March 1998). 

See the FDA guidance for industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (August 2000) at http //www.fda.gov/cvm/guidance/guidel71.pdf.This document provides complementary information on the Biopharmaceutics Classification System. 

FDA/CDER, Guidance for the industry Bioanalytical method validation, May 2001, US Department of Health and Human Services, FDA (CDER) and (CVM), Rockville, MD, USA... 

FDA (2001). Guidance for Industry Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). http //www.fda.gov/cder/guidance/4252fnl.pdf. 

FDA (US Food and Drug Administration) (2003), Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues [freely available at http //www.fda.gov/cvm/ Guidance/guide 118.pdf]. 

This procedure provides the information required to support the sterility assurance of the drug product (product name), USP, manufactured by ABC Pharmaceutical Industries. It references the FDA Guidance titled Guidance for Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Dmg Products prepared by the Sterility Technical Committee of the Chemistry Manufacturing Controls Coordinating Committee of the Center for Dmg Evaluation and Research (CDER) and the Center for Veterinary Medicine (CVM) in November of 1994. 

This guidance was prepared by the CVM at the FDA. For additional copies, access the document on the CVM home page (http //www.fda.gov/cvm/default.html), or send a request to the Communications Staff, HFV-12,7519 Standish Place, Rockville, MD 20855. 

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