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performance characteristics and (2) there is an established scientific framework or body of evidence that elucidates the. For required submissions, complete reports, abbreviated reports, or synopses of pharmacogenomic studies should be submitted to INDs, NDAs, or BLAs in the usual manner. For sponsors, voluntary submission of genomic data offers a number of specific potential benefits: Meet informally with FDA and receive peer review assessments of scientific data from pharmacogenomic experts at the Agency Obtain insight into the evolving regulatory decision making process. However, after the sponsor submits a vgds, if additional information becomes available that triggers the requirements for submission under 312, 314, or 601, the sponsor must submit the data to the relevant application and should follow the appropriate algorithm. We recommend that, to achieve the goals of the vgds process as delineated in Section III(C the content of a vgds, and the level of detail, be sufficient for the Agency to interpret the information and independently analyze the data, verify results, and explore possible. In all of these cases, FDA recommends co-development of the drug and the pharmacogenomic tests, if they are not currently available, and submission of complete information on the test/drug combination to the Agency. . Removal of tissue samples and the reason for removal (e.g., exploratory, mechanistic study, tissue banking) should be specified in the protocol. . Currently, as discussed above, only a few pharmacogenetic tests for certain drug metabolizing enzymes are considered known valid biomarkers in humans. . Compliance with 21 CFR Part 58 The requirements of part 58 apply to nonclinical studies submitted to support safety findings, including nonclinical pharmacogenomic studies intended to support regulatory decision making. .

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A).6 However, we recommend that sponsors or applicants submit reports on all probable valid biomarkers to new (i.e., unapproved) NDAs or BLAs according to the algorithm in section. Given this level of complexity, at the current time, sponsors should consult the relevant FDA review division for advice on how to proceed in a specific case. . The FDA has received numerous inquiries about what these regulations require of sponsors who are conducting such testing. Submission of pharmacogenomic Data. Submission of Voluntary Genomic Data from Application-Independent Research The FDA will also accept pharmacogenomic data from investigators who may not have an active IND, NDA, or BLA, but who wish to provide the information voluntarily to FDA, according to the process described in Section. Because the Agency does not view these studies as germane in determining the safety or effectiveness of a drug, the submission requirements in 314.50 or 601.2 will be satisfied by the submission of a synopsis of the study. .


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