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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...

Hogan Lovells Publications

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.


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...


DEA issues interim final rule implementing 2018 Farm Bill

In the prepublication version of today’s Federal Register, the U.S. Drug Enforcement Agency (DEA) issued an interim final rule (IFR) implementing conforming changes to DEA’s...


FDA creates Coronavirus Treatment Acceleration Program to speed COVID-19 therapy development

The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. The Coronavirus...


FDA permits waivers of some REMS-required laboratory tests, imaging studies due to COVID-19
Registered Content

On March 22, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the...


FDA eases some postmarket adverse event reporting deadlines during COVID-19 pandemic
Registered Content

During the ongoing COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) expects that workforces will be reduced at the same time that the use of medical products will increase....


FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment...

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