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Health Care & Life Sciences

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Firm Highlights

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...

Publication/Podcast

OHRP Issues Guidance on the Conduct of Research During COVID-19 Public Health Emergency

The U.S. Department of Health & Human Services Office for Human Research Protections (“OHRP”) issued guidance , dated April 8, 2020, on the application of Common Rule requirements to research being conducted during the...

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...

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 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...

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...

News

38 Verrill Attorneys, Across Four Offices, Recognized in 2020 Chambers & Partners Guide

(April 27, 2020) – Verrill has been rated as a Leading Firm in a total of ten categories and subcategories as evaluated by London-based Chambers & Partners , one of the world's most respected...

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...

Matter

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.