505 (b)(2) vs. ANDA: How Complex Drugs Fit In
Source: Rho
Choosing the Appropriate New Drug Application and Corresponding Abbreviated Development Pathway
Over the past few years, we have seen some changes in the regulatory environment with a new Drug Competition Action Plan and FDA guidances focused on introducing more competition into the drug market with the goal of increasing access to drugs that consumers need. These guidance documents are meant to provide information on abbreviated approval pathways and provide clarity on the regulatory pathway for complex generic drugs in order to speed approval allowing for more competition in the market place, which may impact pricing.
access the White Paper!
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 Clinical Leader? Subscribe today.
Subscribe to Clinical Leader
X
Subscribe to Clinical Leader
This website uses cookies to ensure you get the best experience on our website. Learn more