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Firm Highlights
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...
Matter
FDA Advertising/Promotion
Presented to senior executives and other management of a start-up pharmaceutical company on complying with U.S. Department of Food and Drug Administration (FDA) advertising and promotion requirements pre- and post-launch.
Publication/Podcast
FDA Announces New Updates to its Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App
On June 3, 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 ” with new information...
Matter
European Union GDPR—Pharmaceutical Company
Advised pharmaceutical company on all aspects of compliance with the European Union General Data Protection Regulation (GDPR), including gap analysis, policy and procedure development, and vendor and other third party contract revisions.
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
On-Site Counsel
Served as on-site, long-term legal counsel for various pharmaceutical and device companies during times of staffing shortage at the companies.
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...
Matter
Informed Consent Form Templates
Developed 23 different types of global research informed consent templates for a major pharmaceutical company along with detailed negotiation guidelines for compliance with applicable laws and best practices.
Matter
CAN-SPAM/E-Sign Act
Acted as the go-to advisor for a pharmaceutical company for advice on CAN-SPAM and E-Sign Act.
Matter
International Clinical Trials
Advised various pharmaceutical companies on the implementation of international clinical trials and related U.S. and ex-U.S. legal issues, including under FDA regulations, Health Insurance Portability and Accountability Act of 1996 (HIPAA), the GDPR, and...
