New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.

Osman MoneerBeatrice L BrownJerry AvornJonathan J DarrowMayookha Mitra-MajumdarKrysten W JoyceMurray RossCatherine PhamAaron S Kesselheim

Published in: Drug safety (2022)

PMRs and PMCs are common for new drugs and can lead to worthwhile outcomes, but are often delayed or incomplete. Greater attention is needed to timely completion, improving transparency of findings, and ensuring that PMRs and PMCs produce optimally useful information for prescribers and patients.

Keyphrases

end stage renal disease
ejection fraction
newly diagnosed
prognostic factors
working memory
emergency department
type diabetes
skeletal muscle
insulin resistance
glycemic control