GE
"The draft guidance describes the Voluntary Genomic Data Submission (VGDS) that can be used for such a voluntary submission. The draft guidance does not recommend a specific format for the VGDS, except that such a voluntary submission be designated a VGDS. The data submitted in a VGDS and the level of detail should be sufficient for FDA to be able to interpret the information and independently analyze the data, verify results, and explore possible genotype-phenotype correlations across studies."
There is no other information on the VGDS, because there are no other guidelines or format specification for it! All in all this is a rather disappointing guideline that doesn't really go very far towards proposing guidelines that the industry can actually comment on. This contrasts somewhat with the following paragraph from the press release:
"The guidance provides specific criteria and recommendations on submission of pharmacogenomic data to investigational new drug applications (INDs) and New Drug Applications (NDAs) and Biological License Applications (BLAs). This includes information on what data is needed, and how FDA will or will not use such data in regulatory decisions."
Indeed the FDA invite very broad comments:
"With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology."
