A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. However, 505(b)(2) products require evidence from clinical trials conducted under an IND in support of the marketing approval application.
All sponsors of clinical trials in the US have to first file an Investigational New Drug (IND) application with the FDA containing extensive preclinical and clinical testing information in support of the proposed clinical trial. Since INDs for 505(b)(2) products rely heavily on the information available about the reference product, creating such an IND raises unique issues. This seminar will discuss the regulatory requirements and logistics for creating an IND application for 505(b)(2) products. This seminar contains a collection of practical tips from the trainer’s extensive IND submission experience.
Why Should you Attend:
Despite being around for more than 25 years, same as generic drugs, the 505(b)(2) products have only recently become more popular. The main reason is that due to several similarities with generic products, 505(b)(2) products offer some unique challenges. Just like NDAs for new drugs, 505(b)(2) products could require several clinical and non-clinical studies and could take a significant allocation of resources, albeit less than that for a brand new product but much higher than that for a generic drug. Like all drug development strategies, 505(b)(2) pathway requires careful consideration and planning taking into account all the potential issues to be addressed before embarking on development. Due to the similarities with traditional drug development, they offer a low risk market entry point by training the work force in the traditional development processes. 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 seminar will discuss the practical strategies for clinical trial approval for such product. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of interactions with the FDA, global clinical trials, and projected trends for the near future.
Objectives of the Presentation:
The seminar aims to clarify the following key concepts:
The 505(B)(2) regulation and guidance from the FDA
Strategic considerations before embarking on a clinical trial for 505(b)(2) products
Key components of an IND application
FDA’s review process and ongoing consultation
Challenges to developing IND for 505(b)(2) products and possible solutions
Examples of successful strategies for developing such products
Searching for a 505(b)(2) project, future trends.
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Who can Benefit:
Sponsors of INDs
Regulatory Affairs Professionals
Senior Management Executives (CEO, COO, CFO, etc)
Drug Discovery and Development Professionals (R&D and CMC)
Intellectual Property Experts
Clinical and Preclinical Laboratory Managers
Project Managers and Clinical Trial Specialists
Regulatory Compliance Associates and Managers
People investing in FDA-regulated product development projects.
Thursday, September 27, 2012
10:00 AM PDT | 01:00 PM EDT
Live Session for one participant
Corporate Live Session 4 to 10 participants in single location.
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.