Article | August 27, 2021

Back To Basics: 505(b)(2) FAQs Part 1

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 are questions that Ken Phelps, our President and CEO, recently answered at a webinar focused on the 505(b)(2) pathway. The topic of this post will be general 505(b)(2) questions, including what is and is not allowed for an approval via the 505(b)(2) regulatory pathway. Stay tuned to this blog for more FAQs and Premier Consulting’s responses in the coming weeks. But first, why the name?


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