Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
News
24 February 2021
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The...
Hogan Lovells Publications
23 February 2021
Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...
Hogan Lovells Publications
16 February 2021
Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...
News
18 September 2020
On September 14, the U.S. Food and Drug Administration (FDA) announced that it released an eight-page update on the status of the Digital Health Software Precertification (Pre-Cert) Pilot...
News
23 August 2020
On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug Administration (FDA) issuances concerning premarket...
News
29 June 2020
Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions...
News
05 May 2020
On May 4, 2020, the U.S. Food and Drug Administration (FDA) updated its policy on COVID-19 test kits, which was originally published on March 16, 2020. In particular, the revised...
News
25 March 2020
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the...
Insights
Registered Content
10 March 2020
The updated, bipartisan Verifying Accurate, Leading-edge IVCT Development Act (VALID Act), creates a regulatory framework for a new product paradigm called in vitro clinical tests (IVCTs),...
