Randy J. Prebula
Partner
Washington, D.C.
Languages
Spanish
Practice Group
Regulatory
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 Cleared First DTC Genetic Tests for Health Risks
Medical Device AlertHogan Lovells Publications
A "Cure" for Combination Products: 21st Century Cures Act Mandates Greater Transparency of Combination Product Designations
Pharmaceutical and Medical Device AlertHogan Lovells Publications
The More the Merrier: Knowing When, Why, and What to Tell FDA About Combination Product Postmarket Events
Medical Device AlertPublished Works
Antimicrobial Resistance Concerns Leach into FDA's Classification of Wound Dressings Containing Drugs
MD+DIHogan Lovells Publications
New FDA Reporting Tool Encourages Whistleblowers
Medical Device AlertHogan Lovells Publications
FDA Finalizes Guidances for Blood Glucose Meters
Medical Device AlertView More
