Drug Trials 'Snapshots' Could Get Photoshopped, CDER Says
Sponsors who disagree with how racial, gender and age-related demographic subgroup data for their products are described in public summaries may propose revisions and submit them for FDA consideration.
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Redesigned FDA.gov is expected to allow application programming interfaces, which could allow other software to talk to the site and potentially use its data.
In an interview, Joseph Gulfo, former medtech industry CEO and vocal FDA critic, outlines his worldview and interest in pushing aggressively against increasing the FDA ‘body of law.’
US FDA received 110 designation requests in July, a high mark that reflects the 60 days needed to review such requests ahead of the 30 September statutory expiration; agency is allowing email submission of RPD and orphan drug designation requests during the COVID-19 pandemic and expects to roll out an online portal for orphan designation requests later this year.