Back To Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies – Pharmacokinetic Studies

By Angela Drew, Ph.D., Product Ideation Consultant, and Olu Aloba, Ph.D., Senior Director of Pharmaceutics

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 the final installment in our 4 part series of frequently asked questions (FAQs).