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Items: 3

1.

Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers.

Kesselheim AS, Rome BN, Sarpatwari A, Avorn J.

Health Aff (Millwood). 2017 Feb 1;36(2):362-370. doi: 10.1377/hlthaff.2016.1340. Epub 2017 Jan 18.

PMID:
28100464
2.

Approval of high-risk medical devices in the US: implications for clinical cardiology.

Rome BN, Kramer DB, Kesselheim AS.

Curr Cardiol Rep. 2014;16(6):489. doi: 10.1007/s11886-014-0489-0. Review.

3.

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

Rome BN, Kramer DB, Kesselheim AS.

JAMA. 2014 Jan 22-29;311(4):385-91. doi: 10.1001/jama.2013.284986.

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