The FDA disagrees with the comments requesting that the FDA be required to inform the applicant, within a set time frame, of potentially problematic financial arrangements, given that the definition of these remedies is inseparable from the review of the application and depends on factors such as the design of the studies and the availability of other data, etc. Concerns arising from financial disclosure are treated like all other concerns arising from the review of a marketing application and are communicated during similar periods. However, as stated in the proposed rule, the FDA strongly recommends early consultation with the Agency in cases where the sponsor of the clinical study is concerned about entering into potentially problematic financial agreements with a clinical reviewer. The FDA amendments, Section 812.43(c), which apply to the selection of monitors and auditors in order to require sponsors to collect financial information from clinicians. While this revision is not indicated in the proposed rule as a compliant change to the product rules, it is consistent with the requirement in Section 812.110(d) that investigators provide sponsors with financial information to obtain the information. This amendment provides that sponsors may obtain financial information from clinical trials prior to the start of clinical trials. This allows the sponsor (and any future applicants) to discover potential biases on the part of the reviewer before the investigation begins and allows the sponsor to consult with the FDA on the management of the situation. This conforming amendment is consistent with the amendment in accordance with subsection 312.53(c). 10. Even in new sec. 54.6.a) and (a) 2, the FDA removed from the proposed rule that sponsors must prove all compensation paid to clinical reviewers and replaced it with a statement inviting applicants to complete records attesting to any financial agreement in accordance with new sections 54.4 (a) (3) (i) and (a) (3) ii). The FDA made the amendment to facilitate registration requirements and require applicants to keep records that could raise potential problematic financial agreements. Similarly, the FDA has revised the compliant amendments to Section 312.57 to facilitate registration requirements and has added Section 812.43(c)(5) to identify requirements for device sponsors.
The FDA has considered various alternatives to publishing this final rule, including the non-transfer of this information to the AMF. Following a meeting with many groups, including the regulated industry and others, it was decided that it was necessary for the FDA to require the submission of this information so that the FDA was duly aware of the influences that could affect data security. The FDA also considered the need to prohibit certain financial interests in which the original reviewer was compensated in a way that could influence the outcome of the study. . . .
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