Description
This guidance provides recommendations for industry and review staff on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for resolving scientific and/or medical disputes between CDER or CBER and sponsors that cannot be resolved at the division level. This guidance describes the formal dispute resolution (FDR) procedures for sponsors that wish to appeal a scientific and/or medical issue to the office or center level and provides a structured process for resolving disputes.
Scope & Applicability
Stakeholders
8Entity responsible for submitting applications under section 524B
Body that may provide review of scientific controversies
Official who facilitates informal resolution of issues
The person assigned to make the decision on the appeal
Administrative contact for all issues related to a request for FDR
Functions as the administrative contact for all issues related to FDRRs
Formal Dispute Resolution Project Manager functions as administrative contact
Final discretionary authority for reviewing user fee appeals.
Regulatory Context
Attributes
2Timeline for deciding official to provide an interim response or decision
Required label element for outsourcing facilities
Related CFR Sections (5)
- 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 →
- 21CFR312.48§ 312.48 Dispute resolution.
(a) General. The Food and Drug Administration is committed to resolving differences between sponsors and FDA reviewing divisions with respect to requirements for IND's as quickly and amicably as possible through the cooperative exchange of information and views.Read full regulation →
- 21CFR314.103§ 314.103 Dispute resolution.
(a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated applications as quickly and amicably as possible through the cooperative exchange of information and views.Read full regulation →
- 21CFR10.35§ 10.35 Administrative stay of action.
(a) The Commissioner may at any time stay or extend the effective date of an action pending or following a decision on any matter.Read full regulation →
- 21CFR14.5§ 14.5 Purpose of proceedings before an advisory committee.
(a) An advisory committee is utilized to conduct public hearings on matters of importance that come before FDA, to review the issues involved, and to provide advice and recommendations to the Commissioner.Read full regulation →
See Also (8)
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development (Status: Final)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
- Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (Status: Final)
- Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (Status: Final)
- How to Write a Request for Designation (RFD): Guidance for Industry (Status: Final)
- Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (Status: Final)
- CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM (Status: Final)
- Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments: Guidance for Industry (Status: Final)