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Safety related label changes for new drugs after approval in the US through expedited regulatory pathways:

Sana R Mostaghim1, Joshua J Gagne1, Aaron S Kesselheim2

  • 1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St, Boston, MA 02120, USA.

BMJ (Clinical Research Ed.)
|September 9, 2017
PubMed

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