Research and Resources

Public Comments

During the review and approval process for animal health products, AHI provides public commentary about issues related to animal health to those federal agencies involved in the review process, including:

 

2014

AHI Comments to FDA on Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
April 3, 2014

2013

AHI Comments to FDA on Draft Guidance for Industry on Bioanalytical Method Validation
December 11, 2013

AHI Comments to FDA on Antimicrobial Animal Drug Sales and Distribution Annual Summary Report Data Tables
November 22, 2013

AHI Comments to FDA on Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection
August 30, 2013

AHI Comments to FDA on the Food and Drug Administration Safety and Innovation Act (FDASIA) Title VII—Drug Supply Chain; Public Meeting
August 9, 2013

AHI Comments to FDA on Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements
July 25, 2013

AHI Comments to FDA on Proposed Rule; Updating Tolerances for Residues of New Animal Drugs in Food
March 4, 2013

AHI Comments to FDA on Final GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals
February 28, 2013

AHI Comments to FDA on Framework for Pharmacy Compounding
January 18, 2013

AHI Comments to FDA on AGDUFA Public Meeting
January 4, 2013

2012

AHI Comments to EPA on Issue Paper: “New” on Pesticide Product Labels
November 20, 2012

AHI Comments to FDA on ANPR for Antimicrobial Animal Drug Sales and Distibution Reporting
October 19, 2012

AHI Comments to FDA on Draft GFI#204 Active Controls in Studies To Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals
August 20, 2012

AHI Comments to FDA on Draft GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209
July 12, 2012

AHI Comments to FDA on Veterinary Feed Directive; Draft Text for Proposed Regulation
July 12, 2012

AHI Comments to FDA on VICH GL51 Statistical Evaluation of Stability Data
May 25, 2012

AHI Comments to FDA on Import Tolerances for Residues of Unapproved New Animal Drugs in Food
April 20, 2012

AHI Comments to CMS on Transparency Reports and Reporting of Physician Ownership or Investment Interests
February 17, 2012

AHI Comments to FDA on GFI 217 Evaluating the Effectiveness of Anticoccidial Drugs in Food Animals
January 23, 2012

2011

AHI Comments to EPA on NPDES CAFO Reporting Rule
December 1, 2011

AHI Comments to FDA on Electronic Standards for Transfer of Data
November 1, 2011

AHI Comments to FDA on 2011 NARMS Meeting
August 11, 2011

AHI Comments to FDA on Periodic Review of Existing Regulations
June 23, 2011

AHI Comments to CDC on Action Plan on Antimicrobial Resistance
June 3, 2011

AHI Comments to FDA on Unapproved Animal Drugs
April 19, 2011

AHI Comments to FDA on National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan
March 21, 2011

AHI Comments to FDA on Improving Transparency to Regulated Industry
February 28, 2011

AHI Comments to FDA on Good Laboratory Practice for Nonclinical Laboratory Studies
February 22, 2011

AHI Comments to FDA on Guidance for Industry #211 Residual Solvents Questions and Answers
January 26, 2011

 

2010

AHI Comments to FDA on eSubmitter Tool
December 28, 2010

AHI Comments to FDA on Revised VICH GL18 Residual Solvents
October 18, 2010

AHI Comments to FDA Antiparasitic Drug Survey
September 10, 2010

AHI Comments to FDA on Guidance for Industry #209 Judicious Use
August 27, 2010

AHI Comments to FDA on Veterinary Feed Directives for Advance Notice of Proposed Rulemaking
August 27, 2010

AHI Comments to FDA Guidance for Industry #188 Data Elements for Adverse Events (AE) Reports
August 9, 2010

AHI Comments to FDA on Transparency Report
July 20, 2010

AHI Comments to FDA on Reporting Falsification of Data
May 17, 2010

AHI Comments to EPA on Pet Spot-On Analysis and Mitigation
May 17, 2010

AHI Comments to FDA on VICH GL46 on Metabolism and Residue Kinetics
May 3, 2010

AHI Comments to FDA on VICH GL47 on Metabolism and Residue Kinetics
May 3, 2010

AHI Comments to FDA on VICH GL48 on Metabolism and Residue Kinetics
May 3, 2010

AHI Comments to FDA on VICH GL49 on Metabolism and Residue Kinetics
May 3, 2010

AHI Comments to EPA on Inert Ingredients
April 23, 2010

AHI Comments to FDA on Using Internet and Social Media
February 24, 2010

2007-2009 Public Comments