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Firm Highlights
Publication/Podcast
COVID-19 Expanded Access Template
We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements...
Matter
Multi-Site Global Research
Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...
Publication/Podcast
Responsible Research During the COVID-19 Pandemic
Publication/Podcast
Updated FDA COVID-19 Guidance for Conduct of Clinical Trials
On March 27, 2020, the U.S. Food & Drug Administration (“FDA”) updated its prior guidance on the “ Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic ,” with an appendix adding a...
Matter
Conflicts of Interest
Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.
Matter
European Union GDPR—Institution
Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...
Publication/Podcast
COVID-19: FDA Clinical Trial Guidance
On March 18, 2020, the U.S. Food & Drug Administration (“FDA”) published guidance for clinical trial sponsors, investigators, and institutional review boards (“IRBs”) on conducting clinical trials in the midst of the COVID-19 pandemic...
News
Michael K. Fee to Lead Verrill’s Health Care and Life Sciences Defense Practice
(January 22, 2020) – Verrill is pleased to welcome Michael K. Fee to the firm’s Boston office as a Partner in its nationally recognized Health Care & Life Sciences Group and as the leader...
Matter
Common Rule
Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.
Publication/Podcast
Due to COVID-19, Federal Agencies Relax Requirements Regarding the Provision of Telehealth Services
In the past few days, in an effort to help keep Medicare beneficiaries healthy during the COVID-19 pandemic, key federal agencies within the U.S. Department of Health and Human Services (“HHS”) and the U.S...