Study: Just half of postmarketing commitment trials are published
A new study published Monday in BMC Medicine finds that only about half of the clinical trials requested by the FDA as part of postmarketing commitments for newly approved drugs and biologics are published in peer-reviewed journals.
The study also found that information for nearly half of the postmarketing commitment studies subject to reporting requirements under section 506B of Federal Food, Drug, and Cosmetic Act (FDCA) was not up to date.
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