Back To Basics: 505(b)(2) FAQs Part 2: Clinical And Nonclinical Studies

By Angela Drew, Ph.D., Product Ideation Consultant

As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Given the growing popularity of the 505(b)(2) pathway for approval of repurposed, reformulated, or unapproved-marketed products, we thought it would be worth providing a refresher. Here is Part 2 in our series of frequently asked questions (FAQs). Stay tuned to this blog for more FAQs and Premier Consulting’s responses in the coming weeks.