Bradley Merrill Thompson, Member of the Firm, will speak on legal perspectives and serves as Chairperson of the “DIA Workshop: Regulatory Considerations for Drug/Device Combinations and Companion Diagnostics.”
FDA expects to receive large numbers of combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers. Because combination products involve components that would normally be regulated under different types of regulatory pathways, and frequently by different FDA Centers, they raise challenging policy, regulatory, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.
This two-day conference provides an understanding of the regulatory frameworks for drug/device combinations and drug/diagnostic pairs. It will focus on the differences between device and drug development processes and regulations, and will highlight regulatory challenges facing developers and manufacturers. FDA will provide updates on regulatory developments and guidance.
How will this meeting meaningfully talk about such a diverse topic as combination products? The workshop will provide an overview of combination products, general principles, and pre- and postmarket considerations. A deeper delve into companion diagnostics will wrap up this interactive conference.
For more information, visit DIAhome.org.