Article | August 27, 2021

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

Regulatory compliance iStock-1256156511

As the 505(b)(2) expert, Camargo, a division of Premier Research, 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).

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