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