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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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Publications

Hogan Lovells Publications

Podcast: Talking the cure

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

HHS now requires public posting of a decade of clinical trial results that were previously exempted

Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical...

News

Buy American EO applies domestic preferences for "essential medicines" and "medical countermeasures"

On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal...

News

FDA extends enforcement discretion period for regenerative medicines, citing COVID-19 challenges

Today, the U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an...

News

Trump administration reversal would take away FDA’s authority to approve biosimilars

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions ...

News

PREP Act declaration amended to clarify coverage of certain products not directly used for COVID-19

On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency...

Hogan Lovells Publications

COVID-19 update: FDA issues minor updates to guidance on hand sanitizer production

In March, the Food and Drug Administration (FDA) issued guidance documents, first revised on March 27, temporarily relaxing certain regulatory requirements for the production of...

Hogan Lovells Publications

HHS Issues Advisory Opinion Encouraging a Broad Reading of its PREP Act Declaration

On April 14, 2020, the Department of Health and Human Services (HHS) General Counsel issued an advisory opinion (“the Opinion”) on the March 10, 2020 Public Readiness and...

News

HHS guidance confers PREP Act immunity to pharmacists for certain COVID-19 tests

On April 8, 2020, the Office of Assistant Secretary for Health (OASH), in the U.S. Department of Health and Human Services (HHS) issued Guidance for Licensed Pharmacists, COVID-19 Test, and ...

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