Practical Strategies to a successful 505(b)(2) product - ComplianceOnline Pharma Training (Pharamaceutical Trai)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Dec 10, 2010 End Date/Time: Dec 10, 2010
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In this 505(b)(2) related webinar, know the complete details, key strategies, regulatory considerations, and marketing strategies for developing 505(b)(2) products.

Why Should You Attend:

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.


Online Event
2600 E. Bayshore Road
Palo Alto
United States