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News

FDA outlines rescission of Breakthrough Therapy Designation

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will...

News

Demy-Colton panel explains how to make your market access strategy real ahead of Phase III trials

Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms, providing companies that are new to the U.S....

News

COVID-19 Report for Life Sciences and Health Care Companies

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

COVID-19 Report for Life Sciences and Health Care Companies (Jan - Feb 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

FDA RWD/RWE regulatory considerations in draft guidance highlight opportunities and challenges

This month, FDA released the latest in a series of agency guidance to advance the development and use of real-world data (RWD) and real-world evidence (RWE) in clinical trial designs for...

News

FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle

The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer...

Published Works

These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D. Life Sciences Connect

Partner Lynn Mehler and Counsel Lowell Zeta pen a guest column for Life Sciences Connect where they discuss the recent appointment of a new Center for Drug Evaluation and Research director...

News

Life sciences and health care horizons 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...

Published Works

Government pandemic response will boost life sciences in 2021 Law360

Looking back on 2020, the repeated lesson is that the challenges wrought by a global pandemic have catapulted our world into a new age.

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