Description
This guidance document describes a recommended approach for resolution of disputes relating to scientific controversies. A scientific controversy involves issues that arise within the context of the Center’s regulation of a specific product and are related to matters of technical expertise that require some specialized education, training, or experience in order to be understood and resolved. The guidance document describes the dispute resolution procedures that we recommend be followed by sponsors, applicants, and manufacturers when requesting review of FDA decisions related to regulated products for animals.
Scope & Applicability
Product Classes
2Safety of residues of veterinary drugs in human food
Products regulated by CVM subject to scientific controversy review.
Stakeholders
9Highest level of appeal within the FDA.
Office within the Commissioner's Office that resolves inter-center disputes and hears appeals.
Authorized to reject a gift; such a decision is final.
A committee that reviews scientific disputes for products regulated by CVM.
Second level of appeal if the applicant disagrees with the Division Director's response.
FDA official who decides whether to accept an SPA request
Coordinates requests for Ad Hoc Appeals Committee or advisory committee review.; Neutral party facilitating dispute resolution and point of contact for the process.
Requests for review of a Center denial should be sent to this official.
entity submitting marketing applications
Related CFR Sections (2)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
See Also (8)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 442.100 New Drugs - Export (Status: Final)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (Status: Final)
- CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (Status: Final)
- CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products (Status: Final)
- CPG Sec. 400.500 Identical or Similar Product Names (Status: Final)