CEO Itescu needs to go, page-51

Type A Meeting.


FDA regulations for dispute resolution (21 CFR 10.75) provide a mechanism for a sponsor/applicant to obtain formal review of any FDA decision by raising the matter with the supervisor of the employee who made the decision. FDA regulations 21 CFR 312.48 and 21 CFR 314.103 address dispute resolution as it relates specifically to investigational new drug applications (IND) and new drug applications (NDA)/abbreviated new drug applications (ANDA), respectively.Formal Dispute Resolution (FDR) is a pathway in CDER by which sponsors/applicants seek to resolve scientific and/or medical dispute that cannot be resolved at the division level. If the issue is not resolved at the division level, the sponsor/applicant may request that the matter be reviewed at the next higher management level. For example, a sponsor/applicant may formally appeal a deficiency cited in a complete response letter, or a reason for a clinical hold.For human drug applications covered by the Prescription Drugs User Fee Act (PDUFA), Biosimilars Drug User Fee Act (BSUFA), or Generic Drugs User Fee Act (GDUFA), FDA will respond to an appeal within 30 days of receipt of the request.A request for formal dispute resolution should be submitted to the appropriate review division as an amendment to the application (e.g., IND, NDA, ANDA, BLA), with a copy to the CDER Formal Dispute Resolution Project Manager (FDRPM). We encourage sponsors/applicants to contact the FDRPM before submitting a request for formal dispute resolution.