FDA DATA SUBMISSIONS
December 1st, 2003
BY MONICA DOBIE
THE UNITED States Food and Drug Administration (FDA) has issued a guide for the US pharmaceutical industry, named "Pharmacogenomic Data Submissions." The document was created to help drug companies comply with a new FDA recommendation that requires firms to submit results of genomic tests when seeking approval for new drugs. * http://www.fda.gov/cder/guidance/5900dft.pdf
THE UNITED States Food and Drug Administration (FDA) has issued a guide for the US pharmaceutical industry, named "Pharmacogenomic Data Submissions." The document was created to help drug companies comply with a new FDA recommendation that requires firms to submit results of genomic tests when seeking approval for new drugs. * http://www.fda.gov/cder/guidance/5900dft.pdf
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