Animal Drug Availability Act of 1996

• The Final Version
  
  
• HR. 2508

Guidance Documents

• Veterinary Feed Directive Regulation [ doc ] [ pdf ], March 1, 2001

• FDA Approval of Animal Drugs for Minor Uses and for Minor Species, September 1997

Federal Register Notices

• Docket No. 93P-0174, CVM 199510. Requirements for Liquid Medicated Animal Feed and Free-Choice Medicated Animal Feed. Pages 31645--31652 May 28, 2003 [FR Doc. 03-12974] | htm | | pdf | Comments August 26, 2003

• CVM 33. Animal Drug Availability Act; Veterinary Feed Directive
  [ htm ] [ pdf ], December 8, 2000

• Presubmission Conferences [ html ] [ pdf ], August 25, 2000

•  Animal Drug Availability Act; Medicated Feed Mill Licenses [ txt ] [ pdf ] November 19, 1999

• Substantial Evidence of Effectiveness of New Animal Drugs.
  [ text ] [ pdf ], July 28, 1999

• Animal Drug Availability Act; Veterinary Feed Directive" 7/2/99
  [ text ] [ pdf ], July 2, 1999

• Request for Comments on Development of Options to Encourage Animal Drug Approvals for Minor Species and for Minor Uses
  June 23, 1997

• FDA Approval of Animal Drugs for Minor Uses and Minor Species; Draft Guidance Document; Availability; Request for Comments 62 Fed. Reg. 50,952, September 29, 1997

• Substantial Evidence of Effectiveness of New Animal Drugs, 62 Fed. Reg. 59,830, Submit written comments on the proposed rule by February 3, 1998. Submit written comments on the information collection requirements by December 5, 1997. Read the text version or view the pdf version. November 5, 1997

• Proposals to Increase the Legal Availability of Animal Drugs for Minor Species and Minor Uses [ text ] [ pdf ], October 29, 1998

CVM Updates

• Proposed Rules for Liquid Medicated and Free-Choice Medicated Feed Available for Comment, May 28, 2003

• FDA Proposed Rules for NADA Presubmission Conferences, August 28, 2000

•  FDA Publishes Final Rule On Medicated Feed Mill Licensing, November 24, 1999

• FDA Publishes Substantial Evidence Final Rule, July 29, 1999

• FDA PROPOSES VETERINARY FEED DIRECTIVE RULES, July 2, 1999

• President Signs Animal Drug Availability Act, October 18, 1996

• Request for Comments on Minor Species and Minor Uses Approval Options, June 26, 1997

• Minor Uses/Minor Species Draft Guidance Published, October 6, 1997

• FDA Publishes Substantial Evidence Proposed Rule, November 6, 1997

• FDA Seeking Comments on a Discussion Draft of MUMS Proposals, December 23, 1997

FDA Veterinarian Newsletter

• Nov/Dec 1996, Vol XI, No. VI

Additional Information

• Working Group Report: Proposals to Increase the Legal Availability of Animal Drugs For Minor Species and Minor Uses [ html ] [ pdf ] - Note: pdf file is better for printing. August 19, 1998

• Update FDA Publishes Adequate and Well-Controlled Studies Final Rule March 16, 1998

• Final Rule Adequate and Well-Controlled Studies for Investigational Use and Approval of New Animal Drugs (pdf) March 5, 1998

• Comments Comments Received on Discussion Draft of MUMS Proposals January 21, 1998

• Cover Letter: CVM Seeks Comments on a Discussion Draft: "Proposals to Increase the Availability of Approved Animal Drugs for Minor Species and Minor Uses" December 19, 1997

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