Animal Health Institute
UnclaimedIndustry
Government Relations
Staff
74
HQ
1325 G St NW, Washington, DC
Phone
+1 202-637-2440
Website
ahi.orgEngagement overview
Animal Health Institute has filed 202 public comments across 163 dockets at 10 federal agencies, most actively at the Food and Drug Administration.
202
Comments filed
163
Dockets engaged
10
Agencies
Jun 11, 2026
Last filing
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Dockets · FDA (128)
sorted by most recent filingFDANonrulemakingFDA-2011-N-0656
Animal Drug User Fee Act; Public Meeting
4 of your filingslast filed Jun 11, 20269 co-filers
FDANonrulemakingFDA-2026-N-0809
Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments.
1 of your filingslast filed Jun 5, 20262 co-filers
FDANonrulemakingFDA-2025-D-1504
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability
1 of your filingslast filed May 8, 20264 co-filers
FDANonrulemakingFDA-2024-D-4689
Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
1 of your filingslast filed Apr 8, 202532 co-filers
FDANonrulemakingFDA-2024-N-5538
National Antimicrobial Resistance Monitoring System 2026-2030 Strategic Plan; Request for Comments
1 of your filingslast filed Mar 28, 20253 co-filers
FDANonrulemakingFDA-2024-D-1054
Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs; Draft Guidance for Industry; Availability
1 of your filingslast filed Mar 25, 20250 co-filers
FDANonrulemakingFDA-1993-D-0285
Guide for Target Animal/Human Food Safety, Anti-Infective Bovine
5 of your filingslast filed Feb 4, 20251 co-filers
FDANonrulemakingFDA-2014-D-1492
Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections
2 of your filingslast filed Nov 19, 20240 co-filers
FDANonrulemakingFDA-2024-D-2978
Animal Food Ingredient Consultation (AFIC); Draft Guidance for Industry; Availability
1 of your filingslast filed Sep 10, 20241 co-filers
FDANonrulemakingFDA-2024-D-1202
Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; Draft Guidance for Industry; Availability
1 of your filingslast filed Aug 27, 20240 co-filers
FDANonrulemakingFDA-2024-D-1668
Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use; Draft Guidance for Industry; Availability
1 of your filingslast filed Aug 27, 20240 co-filers
FDARulemakingFDA-2023-N-5160
Labeling Requirements for Approved or Conditionally Approved New Animal Drugs
1 of your filingslast filed Aug 8, 20241 co-filers
FDANonrulemakingFDA-2024-D-1133
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Pharmaceutical Development; Draft Guidance for Industry; Availability
1 of your filingslast filed Jul 8, 20240 co-filers
FDANonrulemakingFDA-2024-D-1613
Raw Data for Safety and Effectiveness Studies; Draft Guidance for Industry; Availability
1 of your filingslast filed Jul 2, 20240 co-filers
FDANonrulemakingFDA-2023-D-4761
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products; Draft Guidance for Industry; Availability
1 of your filingslast filed Apr 2, 20240 co-filers
FDANonrulemakingFDA-2022-D-0810
Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability
1 of your filingslast filed Mar 29, 20246 co-filers
FDANonrulemakingFDA-2023-D-3740
Priority Zoonotic Animal Drug Designation And Review Process; Draft Guidance for Industry; Availability
1 of your filingslast filed Feb 16, 20240 co-filers
FDANonrulemakingFDA-2023-D-2925
Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Availability
1 of your filingslast filed Jan 12, 20242 co-filers
FDANonrulemakingFDA-2008-D-0053
Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
1 of your filingslast filed Jan 11, 20243 co-filers
FDANonrulemakingFDA-2023-D-2654
Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals; Draft Guidance for Industry; Availability
1 of your filingslast filed Nov 16, 20236 co-filers
FDANonrulemakingFDA-2022-N-0824
Establishing a Public-Private Partnership to Collect and Analyze Antimicrobial Use Data from Food-Producing Animals
1 of your filingslast filed Nov 1, 20234 co-filers
FDANonrulemakingFDA-2023-D-1275
Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry; Availability
1 of your filingslast filed Oct 17, 20230 co-filers
FDANonrulemakingFDA-2023-C-1487
Filing of Color Additive Petition From Environmental Defense Fund, et al.; Request To Revoke Color Additive Listing for Use of Titanium Dioxide in Food
1 of your filingslast filed Sep 5, 20231 co-filers
FDANonrulemakingFDA-1998-D-0038
Microbial Effects of Antimicrobial New Animal Drugs/Human Safety
1 of your filingslast filed Jun 23, 20233 co-filers
FDANonrulemakingFDA-2023-D-0592
Human User Safety in New and Abbreviated New Animal Drug Applications; Draft Guidance for Industry; Availability
1 of your filingslast filed Jun 6, 20230 co-filers
FDANonrulemakingFDA-2023-D-0606
Infectious Otitis Externa Drugs for Topical Use in Dogs; Draft Guidance for Industry; Availability
1 of your filingslast filed May 31, 20231 co-filers
FDANonrulemakingFDA-2022-D-2899
Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability
1 of your filingslast filed May 3, 20230 co-filers
FDARulemakingFDA-2021-N-1351
Revising the National Drug Code Format and Drug Label Barcode Requirements
1 of your filingslast filed Nov 23, 202219 co-filers
FDANonrulemakingFDA-2022-N-2015
FDA Virtual Listening Session on the Regulation of Animal Foods with Certain Types of Claims.
1 of your filingslast filed Nov 18, 202216 co-filers
FDANonrulemakingFDA-2021-N-1305
Antimicrobial Drug Use in Companion Animals; Request for Comments
1 of your filingslast filed Sep 15, 20221 co-filers
FDANonrulemakingFDA-2021-D-1031
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act; Draft Guidance for Industry; Availability
2 of your filingslast filed Sep 1, 20223 co-filers
FDANonrulemakingFDA-1999-D-0188
Efficacy of Anthelmintics for Bovines, Ovines, & Caprines
1 of your filingslast filed Jul 6, 20220 co-filers
FDANonrulemakingFDA-2022-N-0297
Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange; Request for Comments
1 of your filingslast filed May 19, 20220 co-filers
FDANonrulemakingFDA-2020-N-2319
Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments
1 of your filingslast filed Nov 15, 20210 co-filers
FDANonrulemakingFDA-2017-D-2462
The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
1 of your filingslast filed Sep 27, 20210 co-filers
FDANonrulemakingFDA-2016-D-2635
The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration
4 of your filingslast filed Jun 15, 202128 co-filers
FDANonrulemakingFDA-2020-N-1736
Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Public Meeting; Request for Comments
1 of your filingslast filed Mar 16, 20212 co-filers
FDANonrulemakingFDA-2020-N-1764
2020 NARMS Public Meeting
1 of your filingslast filed Nov 13, 20203 co-filers
FDANonrulemakingFDA-2018-D-4533
Compounding Animal Drugs from Bulk Drug Substances; Draft Guidance for Industry; Availability
1 of your filingslast filed Oct 26, 20202 co-filers
FDANonrulemakingFDA-2020-D-1400
Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability
1 of your filingslast filed Oct 15, 20200 co-filers
FDANonrulemakingFDA-2020-D-1401
Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs; Draft Guidance for Industry; Availability
1 of your filingslast filed Oct 15, 20200 co-filers
FDANonrulemakingFDA-2020-D-1402
Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability
1 of your filingslast filed Oct 15, 20200 co-filers
FDANonrulemakingFDA-2020-D-1396
Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability
1 of your filingslast filed Oct 13, 20200 co-filers
FDANonrulemakingFDA-2020-N-0955
Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method; CLOSED
1 of your filingslast filed Oct 2, 20201 co-filers
FDANonrulemakingFDA-2019-D-5664
Standardized Medicated Feed Assay Limits; Draft Guidance for Industry; Availability
1 of your filingslast filed Jun 29, 20200 co-filers
FDANonrulemakingFDA-2019-D-3361
Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs; Draft Guidance for Industry; Availability
1 of your filingslast filed Jan 28, 20201 co-filers
FDANonrulemakingFDA-2019-D-3614
Recommendations for Drug Sponsors for Voluntarily Bringing Under Veterinary Oversight All Medically Important Antimicrobial Drugs Approved for Use in Animals that Continue to be Available as Over-the-Counter Products; Draft Guidance for Industry; Availability
1 of your filingslast filed Jan 7, 20204 co-filers
FDANonrulemakingFDA-2019-N-3019
Transit Times to Slaughter Facilities, Milking Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard Times Assigned to New Animal Drugs; Request for Comments
1 of your filingslast filed Jan 7, 20202 co-filers
FDANonrulemakingFDA-2019-N-2281
Incorporating Alternative Approaches in in Clinical Investigations for New Animal Drugs
2 of your filingslast filed Sep 16, 20190 co-filers
FDANonrulemakingFDA-1976-N-0476
Good Laboratory Practice for Nonclinical Laboratory Studi- Open
2 of your filingslast filed Jan 30, 20191 co-filers
FDANonrulemakingFDA-2018-N-1558
FDA’s Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Request for Comments
1 of your filingslast filed Dec 11, 20181 co-filers
FDANonrulemakingFDA-2018-D-3152
Postapproval Changes to Drug Substances Draft Guidance for Industry; Availability
1 of your filingslast filed Nov 27, 20181 co-filers
FDANonrulemakingFDA-2009-D-0052
Documenting Statistical Analysis Programs and Data
1 of your filingslast filed Oct 30, 20180 co-filers
FDANonrulemakingFDA-1999-D-0754
Draft Guidance on VICH GL9 Good Clinical Practices
2 of your filingslast filed Sep 12, 20180 co-filers
FDANonrulemakingFDA-2018-D-0626
Proprietary Names for New Animal Drugs; Draft Guidance for Industry; Availability
2 of your filingslast filed May 14, 20180 co-filers
FDANonrulemakingFDA-2017-N-5104
Review of Existing Center for Veterinary Medicine Regulatory and Information Collection Requirements
1 of your filingslast filed Feb 14, 20180 co-filers
FDANonrulemakingFDA-2017-N-1197
Proposed Method for Adjusting Data on Antimicrobials Sold or Distributed for Use in Food-Producing Animals Using a Biomass Denominator
1 of your filingslast filed Nov 14, 20175 co-filers
FDARulemakingFDA-2015-N-2002
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products
1 of your filingslast filed May 19, 20171 co-filers
FDANonrulemakingFDA-2016-N-1149
Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products
1 of your filingslast filed Apr 20, 201713 co-filers
FDANonrulemakingFDA-2016-D-2285
Medical Product Communications that are Consistent with the FDA-required Labeling --Questions and Answers; Draft Guidance for Industry; Availability
1 of your filingslast filed Apr 20, 20176 co-filers
FDANonrulemakingFDA-1991-N-0192
Admin Practices and Procedures; Advisory Opinions and Guidelines
1 of your filingslast filed Mar 29, 20172 co-filers
FDANonrulemakingFDA-2016-P-2737
Requests that the FDA withdraw approval of the use of the following medically important antibiotics in livestock and poultry for disease-prevention8 or growth-promotion purposes: macrolides, lincosamides, penicillins, streptogramins, tetracyclines, aminoglycosides, sulfonamides.
1 of your filingslast filed Mar 22, 20171 co-filers
FDANonrulemakingFDA-1996-N-0468
New Animal Drugs for Investigational Use & New Animal Drug Applications
3 of your filingslast filed Feb 14, 20172 co-filers
FDANonrulemakingFDA-2010-N-0548
Good Laboratory Practice for Nonclinical Laboratory Studies
2 of your filingslast filed Jan 23, 20170 co-filers
FDARulemakingFDA-2012-N-1067
New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
2 of your filingslast filed Jan 5, 20170 co-filers
FDANonrulemakingFDA-2005-D-0155
General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
1 of your filingslast filed Sep 20, 20160 co-filers
FDANonrulemakingFDA-2014-N-1050
Exploring the Feasibility of Pursuing Statutory Revisions and Other Modifications to Existing Procedures and Requirements Related to the Approval of Combination Drug Medicated Feeds
2 of your filingslast filed Aug 12, 20161 co-filers
FDANonrulemakingFDA-2011-N-0655
Animal Generic Drug User Fee Act; Public Meeting
2 of your filingslast filed Jun 23, 20161 co-filers
FDANonrulemakingFDA-2005-N-0468
Designation of New Animal Drugs for Minor Uses or Minor Species-CLOSED
1 of your filingslast filed Jan 12, 20161 co-filers
FDANonrulemakingFDA-2015-N-1196
List of Bulk Drug Substances That May be Used by an Outsourcing Facility to Compound Drugs for Use in Animals
1 of your filingslast filed Dec 22, 20151 co-filers
FDARulemakingFDA-2006-N-0239
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
1 of your filingslast filed Dec 15, 20151 co-filers
FDANonrulemakingFDA-1998-N-0088
Exports: Notification and Recordkeeping requirements
1 of your filingslast filed Dec 11, 20150 co-filers
FDANonrulemakingFDA-2015-D-1176
Compounding Animal Drugs from Bulk Drug Substances
1 of your filingslast filed Dec 9, 20151 co-filers
FDANonrulemakingFDA-2000-N-0043
Presubmission Conferences - CLOSED
1 of your filingslast filed Nov 6, 20150 co-filers
FDARulemakingFDA-2015-N-0684
Identification of Alternative In Vitro Bioequivalence Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals
1 of your filingslast filed Oct 5, 20150 co-filers
FDANonrulemakingFDA-2004-D-0372
Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
1 of your filingslast filed Sep 10, 20150 co-filers
FDARulemakingFDA-2012-N-0447
Antimicrobial Animal Drug Sales and Distribution Reporting
3 of your filingslast filed Aug 27, 201523 co-filers
FDANonrulemakingFDA-2010-D-0241
Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
2 of your filingslast filed Mar 12, 20150 co-filers
FDANonrulemakingFDA-2014-D-0758
Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information For Approved Prescription Drugs and Biological Products--Recommended Practices; Availability
1 of your filingslast filed Oct 27, 20140 co-filers
FDANonrulemakingFDA-2014-D-0634
Draft Guidance for Industry on Cell-Based Products for Animal Use; Availability
2 of your filingslast filed Oct 27, 20141 co-filers
FDANonrulemakingFDA-1985-N-0539
Misleading Proprietary or Trade Names For Drugs - CLOSED
1 of your filingslast filed Jun 25, 20140 co-filers
FDANonrulemakingFDA-2013-D-1675
New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products
1 of your filingslast filed Apr 23, 20140 co-filers
FDANonrulemakingFDA-2013-N-1430
Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics; Availability;
1 of your filingslast filed Apr 15, 20140 co-filers
FDARulemakingFDA-1996-N-0027
National Environmental Policy Act Proposed Revision of Policies and Procedures
1 of your filingslast filed Jan 19, 20140 co-filers
FDANonrulemakingFDA-1985-N-0343
Amend Labeling Requirements for Prescription Drugs CLOSED
1 of your filingslast filed Jan 10, 20140 co-filers
FDANonrulemakingFDA-1985-N-0259
Intramammary Infusion Products For Treating Mastitis - CLOSED
1 of your filingslast filed Jan 9, 20140 co-filers
FDANonrulemakingFDA-1977-N-0005
New Animal Drugs for use in Animal Feeds
2 of your filingslast filed Dec 20, 20131 co-filers
FDANonrulemakingFDA-2013-D-0558
Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability
1 of your filingslast filed Aug 7, 20131 co-filers
FDANonrulemakingFDA-2011-D-0784
Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability
2 of your filingslast filed Apr 26, 20130 co-filers
FDANonrulemakingFDA-2012-N-1154
Framework for Pharmacy Compounding: State and Federal Roles
1 of your filingslast filed Jan 23, 201319 co-filers
FDANonrulemakingFDA-2012-D-0419
Draft Guidance for Industry on Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability
1 of your filingslast filed Sep 6, 20120 co-filers
FDANonrulemakingFDA-2011-D-0889
Guidance for Industry on Revising Approved Conditions of Use for New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals to Align with GFI #209; Availability
1 of your filingslast filed Jul 20, 201253 co-filers
FDANonrulemakingFDA-2010-N-0155
Veterinary Feed Directive
2 of your filingslast filed Jul 14, 201244 co-filers
FDANonrulemakingFDA-2012-D-0288
Draft Guidance for Industry on Statistical Evaluation of Stability Data, VICH GL51; Availability
1 of your filingslast filed Jun 13, 20120 co-filers
FDANonrulemakingFDA-2001-N-0075
Regulation for establishing import tolerances
1 of your filingslast filed Apr 30, 20121 co-filers
FDARulemakingFDA-2008-N-0326
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition
2 of your filingslast filed Mar 6, 201272 co-filers
FDANonrulemakingFDA-2011-D-0588
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data (VICH GL35)
1 of your filingslast filed Nov 14, 20110 co-filers
FDANonrulemakingFDA-2011-N-0259
Periodic Review of Existing Regulations; Retrospective Review Under Executive Order 13563
1 of your filingslast filed Jun 28, 20114 co-filers
FDANonrulemakingFDA-2010-N-0528
Unapproved Animal Drugs
2 of your filingslast filed Apr 25, 20113 co-filers
FDANonrulemakingFDA-2010-N-0620
The National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan 2011-2015
1 of your filingslast filed Mar 22, 20113 co-filers
FDANonrulemakingFDA-2009-N-0247
FDA Transparency Task Force; Public Meeting
3 of your filingslast filed Mar 3, 201152 co-filers
FDANonrulemakingFDA-2010-D-0566
Residual Solvents in Animal Drug Products
1 of your filingslast filed Jan 31, 20110 co-filers
FDANonrulemakingFDA-2010-N-0481
Center for Veterinary Medicine eSubmitter Workshop; Public Workshop; Request for Comments
1 of your filingslast filed Dec 29, 20100 co-filers
FDANonrulemakingFDA-2010-N-0420
Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on the Food and Drug Administration Center for Veterinary Medicine Regulated Products Used in Animals
1 of your filingslast filed Nov 10, 20100 co-filers
FDANonrulemakingFDA-2010-N-0307
Agency Information Collection Activities; Proposed Collection; Comment Request; Antiparasitic Drug Survey
1 of your filingslast filed Sep 24, 20101 co-filers
FDANonrulemakingFDA-2010-D-0094
The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
1 of your filingslast filed Sep 3, 201053 co-filers
FDARulemakingFDA-2008-N-0115
Reporting Information Regarding Falsification of Data
1 of your filingslast filed May 18, 20101 co-filers
FDANonrulemakingFDA-2010-D-0164
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Studies To Evaluate The Metabolism And Residue Kinetics Of Veterinary Drugs In Food-Producing Animals: Comparative Metabolism Studies In Laboratory Animals (VICH GL47); Availability
1 of your filingslast filed May 3, 20100 co-filers
FDANonrulemakingFDA-2010-D-0165
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VCM); Availability
1 of your filingslast filed May 3, 20100 co-filers
FDANonrulemakingFDA-2010-D-0166
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Studies To Evaluate The Metabolism And Residue Kinetics Of Veterinary Drugs In Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods (VICH GL48); Availability
1 of your filingslast filed May 3, 20100 co-filers
FDANonrulemakingFDA-2010-D-0163
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Studies to evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Animals: Metabolism Study to determine the Quantity and Identify the Nature of Residues (MRK) (VICH GL46); Availability
1 of your filingslast filed May 3, 20100 co-filers
FDANonrulemakingFDA-2009-N-0441
Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing
1 of your filingslast filed Feb 26, 20102 co-filers
FDANonrulemakingFDA-2009-N-0556
Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience with Approved New Animal Drugs; Proposed New Data Elements for Adverse Event Reports on Revised Forms FDA 1932 and 1932a
1 of your filingslast filed Dec 22, 20090 co-filers
FDANonrulemakingFDA-2008-D-0253
Presenting Risk Information in Prescription Drug and Medical Device Promotion, the FDA Perspective; Draft Guidance for Industry
1 of your filingslast filed Aug 28, 20091 co-filers
FDANonrulemakingFDA-1998-D-1008
Effects of Antimicrobial New Animal Drugs/use in Food-Producing Animals
1 of your filingslast filed Apr 28, 20090 co-filers
FDANonrulemakingFDA-2009-D-0011
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6; Uniformity of Dosage Units General Chapter; Availability
1 of your filingslast filed Apr 15, 20090 co-filers
FDANonrulemakingFDA-2009-D-0013
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 8; Sterility Test General Chapter; Availability
1 of your filingslast filed Apr 15, 20090 co-filers
FDANonrulemakingFDA-2009-D-0012
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7; Dissolution Test General Chapter; Availability
1 of your filingslast filed Apr 15, 20090 co-filers
FDANonrulemakingFDA-2009-D-0001
Draft Guidance for Industry on Standards for Securing the Drug Supply Chain -- Standardized Numerical Identification for Prescription Drug Packages; Availability
1 of your filingslast filed Apr 15, 200917 co-filers
FDANonrulemakingFDA-2008-D-0614
Guidance for Industry on Changes to Approved NADAs —New NADAs vs. Category II Supplemental NADAs
1 of your filingslast filed Feb 12, 20090 co-filers
FDANonrulemakingFDA-2008-D-0559
Guidance for Industry on Process Validation: General Principles and Practices
1 of your filingslast filed Jan 15, 20091 co-filers
FDANonrulemakingFDA-2007-D-0425
Guidance for Industry; Advisory Committee Meetings: Preparation and Public Availability of Information Given to Advisory Committee Members
1 of your filingslast filed Jan 7, 20090 co-filers
FDANonrulemakingFDA-2007-D-0424
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
1 of your filingslast filed Dec 15, 20080 co-filers
FDANonrulemakingFDA-2008-N-0389
Food and Drug Administration Amendments Act of 2007; Section 912 (Prohibition Against Food to Which Drugs or Biological Products Have Been Added)
1 of your filingslast filed Oct 27, 20081 co-filers
FDANonrulemakingFDA-2005-N-0464
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
3 of your filingslast filed Sep 22, 20084 co-filers
FDANonrulemakingFDA-2007-D-0196
Voting Procedures for Advisory Committee Meetings; Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff:
1 of your filingslast filed Aug 7, 20081 co-filers
FDANonrulemakingFDA-2008-N-0176
Defining Small Number of Animals for Minor Use Designation
1 of your filingslast filed Jul 17, 20081 co-filers
FDANonrulemakingFDA-2008-N-0082
Animal Drug User Fee Act; Public Meeting
2 of your filingslast filed Apr 12, 20082 co-filers
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