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.
Resources
ExperienceFirm Highlights
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.
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
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
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...
