FDA's Veterinary Regulators Eye Dozens of Policy Changes in 2015
The US Food and Drug Administration's (FDA) veterinary regulatory division, the Center for Veterinary Medicine (CVM), plans to release 31 new or updated policies in 2015, it has confirmed.
In a notice posted on FDA's website last week, CVM announced top-level details about which guidance documents it plans to release in the coming year. Guidance documents are non-binding expressions of policy, and indicate how FDA wants members of the life science industry to comply with its existing regulations.
The planned guidance documents—31 in all—cover a wide range of topics.
For example, FDA says it is planning a brand new policy on how companies may (or may not) market unapproved new animal drugs.
Other policies are set to cover the development of fixed-dose combination drugs for animals, cellular therapies for animals, a revision of FDA's policy on developing drugs for uncommon diseases or for uncommon species, and the use of proprietary (i.e. "brand") names on drug labeling.
The full list of guidance documents under development may be found below. Though FDA says it plans to release all documents by the end of 2015, the agency has historically only managed to get to a fraction of the documents each year.
| Title of Guidance |
|---|
| Draft Guidance for Industry – Marketed Unapproved New Animal Drugs |
| Draft Guidance for Industry – Compounding Animal Drugs from Bulk Drug Substances |
| Guidance For Industry (GFI #61) - FDA Approval of Animal Drugs for Minor Uses and for Minor Species (Revision) |
| Draft Guidance for Industry (GFI #210) – The Indexing of Legally Marketed Unapproved New Animal Drugs for Minor Species |
| Guidance for Industry (GFI #225) – Electronic Exchange of Documents: File Format Requirements – VICH GL53 |
| Guidance for Industry (GFI #224) – Bioequivalence: Blood Level Bioequivalence Study – VICH GL52 |
| Draft Guidance for Industry – Combination New Animal Drugs |
| Guidance for Industry (GFI #218) – Cell-Based Products for Use in Animals |
| Draft Guidance for Industry (GFI #228) – Designing Effectiveness Studies for Common Animal Production Indications (Growth, Feed Efficiency, Carcass Leanness, Reproduction, Milk Production) |
| Draft Guidance for Industry (GFI #229) - Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle |
| Guidance for Industry (GFI #23) – Medicated Free Choice Feeds (Revision) |
| Draft Guidance for Industry – Medicated Feed Assays |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) |
| Draft Guidance for Industry (GFI #57) – Preparation and Submission of Veterinary Master Files (Revision) |
| Draft Guidance for Industry – Question-Based Review for Animal Drugs |
| Guidance for Industry – Submitting Two-Phased Chemistry, Manufacturing and Controls (CMC) Technical Sections |
| 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) |
| Guidance for Industry (GFI #208) – Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food Producing Animals: Validation of Analytical Methods used in Residue Depletion Studies – VICH GL49 (Revision) |
| 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 GL54 |
| Draft Guidance for Industry – Presenting and Analyzing Target Animal Safety Study Data |
| Guidance for Industry (GFI #171) – Waivers of In Vivo Demonstration (Revision) |
| Draft Guidance for Industry – Proprietary Names on Drug Labeling |
| Guidance for Industry (GFI #221) – Recommendations for Preparation and Submission of Animal Food Additive Petitions |
| Guidance for Industry (GFI #80) – Effectiveness Studies for Anti-Salmonella Animal Food Additives (Revision) |
| Draft Guidance for Industry – Design and Submission of Distributor Labeling |
| Guidance for Industry (GFI #220) – Use of Nanomaterials in Food for Animals |
| 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 |
| Draft Guidance for Industry - Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients |