To help clients effectively address the challenges involved in achieving compliance with the ever-increasing variety of regulatory requirements, we invite you to join us for a new webinar series. Each one-hour program will offer practical guidance from our experts pertaining to one of today’s most pressing regulatory issues.
The first presentation in the series provides a high-level overview of select FDA and healthcare regulatory and enforcement policy changes that impact the industry, including regulatory and risk management considerations for clinical trials and relaxation of certain FDA and healthcare regulations that help to facilitate companies in their development and commercialization of their products. The following topics will be covered during this webinar:
Juliana Campbell
jcampbell@wsgr.comGeorgia Ravitz is a partner in the life sciences practice of Wilson Sonsini Goodrich & Rosati, where she specializes in FDA regulatory, healthcare, and consumer products innovation and compliance. In particular, she focuses on food and drug law and regulatory policy governing the regulation and promotion of medical devices, pharmaceuticals (including OTCs), health and beauty aids (cosmetics), dietary supplements, vitamins, food and agribusiness, tobacco and e-cigarettes, cannabis, and a wide variety of consumer goods and emerging consumer technologies. She counsels U.S. and foreign manufacturers, distributors, retailers, and importers of regulated products in all phases of their product lifecycle, from innovation through product commercialization and ongoing post-market compliance.
Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.