@article{ref1,
title="Post-market safety communication for protection of public health: a comparison of regulatory policy in Australia, Canada, the European Union, and the United States",
journal="Clinical pharmacology and therapeutics",
year="2020",
author="Bhasale, Alice L. and Sarpatwari, Ameet and De Bruin, Marie L. and Lexchin, Joel and Lopert, Ruth and Bahri, Priya and Mintzes, Barbara J.",
volume="ePub",
number="ePub",
pages="ePub-ePub",
abstract="In the wake of the rofecoxib withdrawal, regulators worldwide reconsidered their approach to post-market safety. Many regulators have since adopted a life-cycle approach to regulation of medicines, facilitating faster approval of new medicines while recognising and planning for post-market safety issues. A crucial aspect of post-market safety is the effective and timely communication of emerging risk information using post-market safety advisories, commonly issued as letters to healthcare professionals, drug safety bulletins, media alerts and website announcements. Yet regulators differ in their authority to issue post-market safety advisories. We examined the capacity of regulators in the United States, Europe, Canada, and Australia to warn about post-market safety issues by examining their governance, legislative authority, risk communication capabilities, and transparency.<p /> <p>Language: en</p>",
language="en",
issn="0009-9236",
doi="10.1002/cpt.2010",
url="http://dx.doi.org/10.1002/cpt.2010"
}