Back To Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies – Pharmacokinetic Studies
Source: Premier Consulting
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).
access the Article!
Log In
Get unlimited access to:
Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue.
X
Enter your credentials below to log in. Not yet a member of Cell & Gene? Subscribe today.
Subscribe to Cell & Gene
X
Subscribe to Cell & Gene
Premier Consulting
This website uses cookies to ensure you get the best experience on our website. Learn more