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Firm Highlights
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
FDA Updates its Guidance on Conducting Clinical Trials During COVID-19 Public Health Emergency
On April 16, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” adding seven new questions and...
News
Nearly 80 Verrill Attorneys Recognized by Best Lawyers® 2021, Including a Dozen Named Lawyers of the Year
(August 24, 2020) – Nearly 80 Verrill attorneys were recognized as "Best Lawyers" by Best Lawyers® 2021 , including 12 attorneys named “Lawyer of the Year,” a distinguished recognition for only a single lawyer...
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.
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...
News
Michael K. Fee to Lead Verrill’s Nationally-Recognized Health Care and Life Sciences Practice Amidst Recent Changes
(August 31, 2020) – Verrill is pleased to announce Michael K. Fee as the new leader of Verrill’s nationally-recognized Health Care & Life Sciences Group. The Group has a long history of representing a...
Matter
Conflicts of Interest
Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.
Publication/Podcast
EU-U.S. Privacy Shield Invalidated: Does Your Company Have a Plan B?
On Thursday, July 16, 2020, the Court of Justice of the European Union (“CJEU”) invalidated the EU-U.S. Privacy Shield (“Privacy Shield”) in Data Protection Commissioner v. Facebook Ireland and Maximillian Schrems (Case C-311/18...
Publication/Podcast
FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19
Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines...
Publication/Podcast
News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including COVID-19 LDTs
What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket review of Laboratory...
