An industry group representing pharmaceutical and biotechnology companies is asking the US Food and Drug Administration (FDA) not to require the reporting of results from exploratory pharmacogenomic studies, saying it could disincentivize companies from performing these studies at all.
The comments, from the Industry Pharmacogenomics Working Group (I-PWG), are in response to the agency’s draft guidance on Pharmacogenomic Data Submissions, issued in March 2023. The guidance outlines the types of pharmacogenomic study findings and data that must be included for investigational new drug applications (INDs), new drug applications (NDAs) and biologics license applications (BLAs)…
