Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA postmarketing requirements

Nabhan C et al. JAMA Oncol. 2018 May 10. doi:10.1001/jamaoncol.2018.0610.

Key clinical point: Of 49 oncology drugs approved by the FDA from January 2011 to December 2016, 23 were given accelerated approval, with 17 needing postmarketing research.

Major finding: None of the pending or ongoing studies are behind their original schedules.

Study details: A review of the FDA’s Novel Drugs Summary, the FDA’s Postmarket Requirements and Commitments database, and Clinicaltrials.gov information.

Disclosures: No disclosures were reported.

Source: Nabhan C et al. JAMA Oncol. 2018 May 10. doi:10.1001/jamaoncol.2018.0610.

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Citation:

Nabhan C et al. JAMA Oncol. 2018 May 10. doi:10.1001/jamaoncol.2018.0610.