Practical Strategies to a successful 505(b)(2) product - ComplianceOnline Pharmaceutical Training 2010

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.

Areas Covered in the Seminar:

• The 505(B)(2) regulation and guidance from the FDA.
• Strategic considerations before embarking on a 505(b)(2) development project.
• Intellectual property issues with such products.
• Key development steps for such products.
• FDA s review process and ongoing consultation.
• Challenges to developing 505(b)(2) product and possible solutions.
• Examples of successful strategies for developing such products.
• Searching for a 505(b)(2) project, future trends.
• 505(b)(2) and biosimilars.