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...
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.
Acted as the go-to advisor for a pharmaceutical company for advice on CAN-SPAM and E-Sign Act.
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...
Served as on-site, long-term legal counsel for various pharmaceutical and device companies during times of staffing shortage at the companies.
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...
The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to...
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...
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.
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.
