Regulatory bodies and health care systems should systematically evaluate the safety and cost-effectiveness of new cardiovascular treatments in health care registries using prospectively designed protocols-Reference-Cited by-同舟云学术

Regulatory bodies and health care systems should systematically evaluate the safety and cost-effectiveness of new cardiovascular treatments in health care registries using prospectively designed protocols

Published:2024-05-02 Issue:1 Volume:58 Page:
ISSN:1401-7431
Container-title:Scandinavian Cardiovascular Journal
language:en
Short-container-title:Scandinavian Cardiovascular Journal

Author:

Redfors Björn¹²

Affiliation:

1. Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden

2. Clinical Trial Center, Cardiovascular Research Foundation, NY, USA

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/14017431.2024.2343383

Reference11 articles.

1. 2017/745 Of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC;Regulation (EU;OJ L,2017

2. No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC;Regulation (EU;OJ L,2014

3. Code of Federal Regulations (CFR). Title 21 Part 312 - Investigational New Drug Application. U.S. Food and Drug Administration. [cited 2023 May 7]. Available at https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4e36990a5a57b3d4b4f96bfe6170b59e&ty=HTML&h=L&mc=true&=PART&n=pt21.5.312.

4. Code of Federal Regulations (CFR). Title 21 Part 812 - Investigational Device Exemptions. U.S. Food and Drug Administration. [cited 2023 May 7]. Available at https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4e36990a5a57b3d4b4f96bfe6170b59e&ty=HTML&h=L&mc=true&=PART&n=pt21.8.812.

5. Reform of Drug Regulation — Beyond an Independent Drug-Safety Board