The cost of development and the uncertainty of regulatory review make the development of new drugs, and even new forms of older drugs, a risky proposition. Generic drugs can utilize the ANDA pathway or, with some allowed changes, the 505(j)(C) regulatory route. This simplifies the development process and greatly shortens the time to market for products that fit the definition. But what if your product cannot fit the generic definition for approval through an abbreviated pathway? In this situation, many companies employ a 505(b)(2) strategy.
This presentation is designed to help regulatory executives understand some of the nuances of these two regulatory pathways. Our speakers clarify the processes involved in the ANDA and the 505(b)(2), and examine the advantages and disadvantages of both.
ANDA vs. 505(b)(2): When and Why? is being presented by Joel Falk & Dr. Nick Fleischer, Executive Vice President & Vice President, with The Weinberg Group and airs on Thursday, January 14, 2010. For more details or to register, please visit our site at www.fxconferences.com
