Joshua Oyster

Josh Oyster steers clients through a wide range of FDA regulatory issues to help them bring innovative products to market while also ensuring regulatory compliance. Josh counsels leading life sciences and health care companies, including biopharmaceutical and medical device manufacturers, academic medical centers, and clinical research organizations, as well as private equity firms and investment banks focused on investing in these sectors.

With a deep command of the subject matter—and a talent for translating complex regulations into practical, strategic advice—Josh is regularly called upon to advise on high-stakes enforcement, regulatory compliance and transactional matters. Josh routinely helps companies navigate FDA inspections, warning letters, product recalls, and other compliance and enforcement matters. He is frequently tapped to solve his clients’ most-pressing challenges related to novel, complex, or ambiguous regulatory requirements. Josh’s counseling draws on his extensive experience with key policy and enforcement priorities, including medical product promotion, digital health, data integrity, laboratory-developed tests, drug compounding, and controlled substance diversion. In addition, Josh assists clients in assessing regulatory risks associated with potential acquisitions and investments in FDA-regulated entities.

What clients appreciate most about Josh is his ability to see the big picture and provide practical legal advice that is tailored to a company’s business objectives and circumstances. With prior in-house and secondment experience at leading health care and life sciences companies, Josh can readily connect with clients’ internal teams to offer clear, timely advice to both lawyers and non-lawyers.

Josh frequently writes about cutting-edge regulatory issues affecting life sciences companies and presents at industry conferences.