With a new administration and a new commissioner now in place, the U.S. Food and Drug Administration is changing.
In this exclusive Podcast, Vascular Sciences’ President, and part-time FDA consultant, Dr. Michael Drues addresses what these changes may mean to manufacturing, packaging, and labeling functions within the pharmaceutical, biologic, and medical device community?
In a discussion with Healthcare Packaging editor Jim Butschli, Drues offers his perspective on the commonly used 510(k) process for medical devices, and points out a recent safety-related issue pertaining to the packaging of a well-recognized OTC product. Drues concludes by recommending that healthcare packagers partner with the FDA rather than viewing the agency as an obstacle.
