ANDA vs. 505(b)(2): When and Why?

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

FDA's New Enforcement Strategy: The Growing Perils of Inadequate Compliance

On August 6th, FDA Commissioner Margaret Hamburg outlined the agency’s new enforcement strategy and her plan for creating “a strong FDA.” With greater scrutiny and a more streamlined enforcement process, it is critical that firms be prepared to respond and take corrective action quickly upon receiving a warning letter. This audio conference is designed to help senior life science executives understand what the new strategy means to them, how to maximize the chances that an FDA inspection will not trigger additional agency enforcement action and, if it does, how to respond.

FDA's New Enforcement Strategy: The Growing Perils of Inadequate Compliance is being presented by Matthew Weinberg & Michael Swit, CEO & Vice President, with The Weinberg Group and airs on Wednesday, December 9, 2009. For more details or to register, please visit our site at www.fxconferences.com