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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
News
01 March 2022
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....
News
11 January 2022
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
News
27 August 2021
Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of...
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
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 and Analysis
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),...
Insights and Analysis
09 March 2020
Recent data from the U.S. Food and Drug Administration (FDA or the agency) on the percentage of De Novo classification requests that are declined or withdrawn raises questions about the...
News
02 March 2020
The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket...
News
25 September 2019
On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk...
