Knowledge

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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Publications

News

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations...

News

FDA issues list of essential medicines and countermeasures required under Buy American Executive Order

Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration...

News

DEA proposes revised rules for identifying and reporting suspicious orders of controlled substances

Today, the U.S. Drug Enforcement Administration (DEA) released its long-awaited proposed rule on Suspicious Orders Monitoring System (SOMS) obligations under the federal Controlled...

Insights

Navigating the new ‘buy American’ drug landscape: opportunities for some, pitfalls for others
Registered Content

President Trump’s executive order on essential medicines aims to encourage pharmaceutical companies to bring their manufacturing back to the U.S. But it may also have...

News

FDA, CMS actions on drug importation promise much, likely deliver little

Recently, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced policies intended to permit the importation of, and Medicaid...

Insights

Therapeutic cannabis in France: publication of the decree authorising the experiment
Registered Content

After months of waiting, decree no. 2020-1230 of 7 October 2020 authorises the therapeutic cannabis experiment in France and sets the implementation modalities. Many points are still...

News

FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when...

News

COVID-19 Report for Life Sciences and Health Care Companies (21 - 24 September 2020)

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...

News

COVID-19 Report for Life Sciences and Health Care Companies (14 - 18 September 2020)

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...

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