PHARMACEUTICALS 2010 - Practical Strategies to a successful 505(b)(2) product - Pharmaceuticals webinar By ComplianceOnline

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Category Pharmaceuticals,conference,event,Webinar

Deadline: December 10, 2010 | Date: December 10, 2010

Venue/Country: Palo Alto, U.S.A

Updated: 2010-12-03 19:54:42 (GMT+9)

Call For Papers - CFP

A 505(b)(2) products is an improved or altered version or a new use application for a previously FDA-approved drug. Every year FDA approves about twice the number of 505(b)(2) applications compared to traditional 505(b)(1) applications. It is projected that due to increased challenges in creating new products, 505(b)(2) products might comprise more than 70% of all FDA approvals over the next 10 years. This pathway is particularly attractive to manufacturers transitioning from generic drugs to innovator products.

However, as would be evident, there are unique challenges to developing such products ? scientific, regulatory, logistical and financial ? all of which could convert a potentially attractive project into a constant headache.

This 505(b)(2)webinar will discuss the practical strategies for drug development via 505(b)(2) regulatory pathway. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of interactions with the FDA, global clinical trials, market access, reimbursement issues and projected trends for the near future. Lastly, the 505(b)(2) pathway will be compared to that for biosimilars.

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