July 31, 2024
Blog
Recent Posts
March 19, 2024
Regulatory
Data information and disclosurePart 3 Author: Dr. Cheryl L. Rowe-Rendleman Some exciting new changes were announced in 2023 that... read moreNovember 30, 2023
Conducting Clinical Trials
Part 2Author: Dr. Cheryl L. Rowe-Rendleman In the United States, “biological products” are subject to a different premarket pathway and differing intellectual property protections than products regulated as “drugs”.... read moreOctober 16, 2023
Obtaining Early Regulatory Advice — INTERACT Meetings
Part 1Author: Dr. Cheryl L. Rowe-Rendleman In the United States, “biologic products” are subject to a different premarket pathway than products regulated as “drugs”. This 3-part blog series describes... read moreMarch 14, 2023