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The Experience with Voluntary Genomic Data Submissions at the FDA and a Vision for the Future of the Voluntary Data Submission Program
Author(s) -
Orr M S,
Goodsaid F,
Amur S,
Rudman A,
Frueh F W
Publication year - 2007
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100053
Subject(s) - food and drug administration , drug development , data science , drug , turnover , medicine , computer science , pharmacology , management , economics
Drug developers have been using genomic information in drug development strategies for a number of years, but it was unclear how this information would be reviewed by the Food and Drug Administration (FDA). In order to evaluate the regulatory impact of genomic data in current drug development, a workshop was held in May 2002 to discuss aspects surrounding genomic data submission to the FDA (Figure 1).