Regulatory Focus™ > News Articles > FDA's Veterinary Division Plans to Release Dozens of Regulatory Guidances in 2014

FDA's Veterinary Division Plans to Release Dozens of Regulatory Guidances in 2014

Posted 23 January 2014 | By Alexander Gaffney, RAC

US veterinary product regulators from the Center for Veterinary Medicine (CVM) have released the first of the US Food and Drug Administration's (FDA) guidance agendas for the year, highlighting a range of policy initiatives they aim to undertake in the coming months.

FDA, CVM's parent organization, is in the practice of releasing so-called "guidance agendas" at the beginning of each year, and sometimes updating it several times throughout the year. The intent is to allow industry to better understand the number and scope of regulatory activities it will need to account for in the coming year, as well as to coordinate regulatory activities with specific guidance documents.

While guidance documents do not have the force of law or regulation, in practice they are often treated as such and represent something of a "path of least resistance" through the regulatory review process.

2014 Guidance Agenda

CVM's newest guidance agenda contains 33 guidance documents, a combination of draft, final, new and old documents. Of the 33, 24 are new guidance documents (draft or final) dealing with veterinary drugs, while six are revisions to existing guidance documents and three are food-related guidances.

The documents are also a mix of documents focused on medical feed topics and veterinary drugs. Some are tried-and-true regulatory topics, such as Chemistry, Manufacturing and Controls (CMC) Guidances for Generic New Animal Drugs and Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients.

Others, though, get into trickier topics. Labeling and Marketing of Dog and Cat Food Products Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases promises to be something of a medical foods guidance for household pets. Cell-Based Products for Use in Animals is meant to discuss the use of biological medicines in animals-a type of medicine more often seen in humans.

And two guidances, Proprietary Names on Drug Labeling and Design and Submission of Distributor Labeling are set to bring more stability to veterinary drug labels.

FDA said all guidances should be published by the end of December 2014. If past is prologue, though, you can bet on at least a few still being unfinished and unpublished when December ends.

2014 Guidance Agenda

Veterinary Drug Guidances (New)

Draft Guidance for Industry - Marketed Unapproved New Animal Drugs

Draft Guidance for Industry (GFI #210) - The Indexing of Legally Marketed Unapproved New Animal Drugs for Minor Species

Draft Guidance for Industry - Electronic Exchange of Documents: File Format Requirements - VICH GL53

Draft Guidance for Industry - Bioequivalence: Blood Level Bioequivalence Study - VICH GL52

Draft Guidance for Industry - Combination New Animal Drugs

Draft Guidance for Industry (GFI #218) - Cell-Based Products for Use in Animals

Draft Guidance for Industry - Designing Effectiveness Studies for Common Animal Production Indications (Growth, Feed Efficiency, Carcass Leanness, Reproduction, Milk Production)

Draft Guidance for Industry - Medicated Feed Assays

Draft Guidance for Industry - Chemistry, Manufacturing and Controls (CMC) Guidances for Generic New Animal Drugs

Draft Guidance for Industry - Development of In Vivo In Vitro Correlation (IVIVC) for Sustained Released Injectables (SRI)

Guidance for Industry (GFI #219) - Statistical Evaluation of Stability Data - VICH GL51(R)

Draft Guidance for Industry - Question-Based Review for Animal Drugs

Draft Guidance for Industry - Submitting Two-Phased Chemistry, Manufacturing and Controls (CMC) Technical Sections

Draft Guidance for Industry - Human Food Safety for Protein/Peptide Drugs

Guidance for Industry (GFI #116) - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing - VICH GL23(R)

Draft Guidance for Industry - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD) - VICH

Draft Guidance for Industry - Presenting and Analyzing Target Animal Safety Study Data

Draft Guidance for Industry - Proprietary Names on Drug Labeling

Draft Guidance for Industry - Design and Submission of Distributor Labeling

Draft Guidance for Industry (GFI #203) - Ensuring Safety of Animal Food Maintained and Fed On-Farm

Compliance Policy Guide - Labeling and Marketing of Dog and Cat Food Products Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases (Final)

Draft Guidance for Industry - Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients

Guidance for Industry (GFI #143) - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms - VICH GL30

Guidance for Industry (GFI #214) - Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data - VICH GL35(R)

Veterinary Drug Guidances: Revised

Guidance For Industry (GFI #79) - Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (Revision)

Guidance For Industry (GFI #61) - FDA Approval of Animal Drugs for Minor Uses and for Minor Species (Revision)

Guidance for Industry (GFI #23) - Medicated Free Choice Feeds (Revision)

Draft Guidance for Industry (GFI #57) - Preparation and Submission of Veterinary Master Files (Revision)

Guidance for Industry (GFI #171) - Waivers of In Vivo Demonstration (Revision)

Guidance for Industry (GFI #207) - 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 (Revised)

Food Guidance Documents

Draft Guidance for Industry (GFI #220) - Use of Nanomaterials in Food for Animals

Draft Guidance for Industry - Preventive Controls for Food for Animal Foods Under FSMA

Guidance for Industry (GFI #80) - Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds (Revised)


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