Drugs and Devices

Author:

Van Norman Gail A.

Funder

American College of Cardiology Foundation

Publisher

Elsevier BV

Subject

Cardiology and Cardiovascular Medicine

Reference84 articles.

1. Comparison of drug approval process in United States and Europe;Kashyap;J Pharm Sci Res,2013

2. Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments;Wild;BMC Cardiovasc Disord,2014

3. Regulation of medical devices in the United States and European Union;Kramer;N Engl J Med,2012

4. Institute of Medicine. Medical Devices and the Public's Health: the FDA 510(k) Clearance Process at 35 Years. Washington, DC: National Academies Press, 2011. Available at: http://www.nationalacademies.org/hmd/∼/media/Files/Report%20Files/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/510k%20Clearance%20Process%202011%20Report%20Brief.pdf. Accessed June 3, 2016.

5. Gaffney A. Bill Wants Drugs Approved in Europe to Be Available More Quickly to US Patients. Regulatory Focus March 15, 2015. Regulatory Professional Affairs Society. Available at: http://www.raps.org/Regulatory-Focus/News/2015/03/20/21778/Bill-Wants-Drugs-Approved-in-Europe-to-be-Available-More-Quickly-to-US-Patients/. Accessed May 28, 2016.

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