Filter content by category:
Regulatory Consulting
Exploring Benefits, Eligibility, and Key Considerations for Sponsors Pursuing Orphan Drug Designation
Pursuing Orphan Drug Designation? Navigating the nuances of eligibility and the application process can be complex.
February 18, 2025
Medical Device Clinical Trials: Classification & Challenges
(Originally submitted to surfaces.org’s SurFACTS in Biomaterials Volume 26 Issue 3.) An overview of medical device clinical trials, discussing device classification and challenge unique from drug/biologics trials.
December 2, 2021