Randy J. Prebula
Partner
Washington, D.C.
Languages
Spanish
Whether describing complex science in straightforward terms to lawyers or translating premarket and compliance regulatory requirements to scientists, Randy Prebula focuses practical experience and a deep understanding of FDA regulations to help clients navigate the intersections of science, policy, and law.
As a key resource for medical device, drug, human tissue, and combination product manufacturers, Randy works seamlessly with clients, internal teams, and across borders to help bring innovative medical products to market and meet patient needs throughout each product's unique life cycle.
He brings not only a wealth of experience in immunology, biochemistry, and new product development, but he also provides real-world experience in developing, implementing, and maintaining compliant regulatory systems and procedures.
Areas of Focus
Representative Experience
Latest thinking and events
Hogan Lovells Publications
FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests
Medical Device AlertHogan Lovells Publications
New EMC Guidance Released by FDA
Medical Device AlertHogan Lovells Publications
FDA Takes Steps to Clarify Significant Human Tissue Questions
Medical Device, Pharmaceutical, and Biotechnology AlertHogan Lovells Publications
Draft Guidance on General Considerations for Animal Studies
Medical Device AlertHogan Lovells Publications
Carrier Testing Update
Medical Device AlertHogan Lovells Publications
DuPont's Upgraded Manufacturing Process Regarding Their Tyvek® Material and Impact on Medical Device Manufacturers
Medical Device AlertView More
