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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.

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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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

Protecting biomedical innovation as a national security asset

In recent years, it has become fashionable to focus on the high price of new treatments for certain cancers and rare diseases. Many observers ask why it is that U.S. citizens should...

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

Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug...

News

UK post-Brexit regulation of medicines from 1 January 2021

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate...

Insights

The CRA: Schumer-led Senate Could Overturn Trump Deregulatory Legacy
Registered Content

In the event that Joe Biden becomes President, and the Senate shifts to Democratic control, it is highly likely that the Democratic congress’ early 2021 agenda will involve the use of ...

News

China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs

On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the...

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

China’s drug regulator seeks comments on updated drug recalls regulation

On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly...

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