505(b)(2) Submissions: Eligibility, Strategies & Preparation

is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, November 16th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

There are a variety of scenarios under which information that is not generated by an applicant could be useful to support a submission for drug approval under Section 505(b)(2) of the FDC Act. In developing a strategy, one must consider the quickest route to approval, the best labeling and the broadest use supported by the data. Depending on the products to be submitted for approval (changes to an approved drug, a marketed unapproved drug, or a new chemical entity with previously published information), the scope and the extent of the available information will have an impact on the bridging (nonclinical, clinical) studies to be performed and submitted.

In this conference, the speaker describes the drugs that can and cannot be submitted under Section 505(b)(2), strategies for different products, the role of patents and marketing exclusivity, and types of bridging studies. He also shares insights into search strategies to obtain and select appropriate published literature references, preparation of summaries, use of previous agency findings of safety and effectiveness, and the potential pitfalls in using published literature findings and agency findings.

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

505(b)(2) Submissions: Eligibility, Strategies & Preparation

There are a variety of scenarios under which information that is not generated by an applicant could be useful to support a submission for drug approval under Section 505(b)(2) of the FDC Act. In developing a strategy, one must consider the quickest route to approval, the best labeling and the broadest use supported by the data. Depending on the products to be submitted for approval (changes to an approved drug, a marketed unapproved drug, or a new chemical entity with previously published information), the scope and the extent of the available information will have an impact on the bridging (nonclinical, clinical) studies to be performed and submitted.

In this conference, the speaker describes the drugs that can and cannot be submitted under Section 505(b)(2), strategies for different products, the role of patents and marketing exclusivity, and types of bridging studies. He also shares insights into search strategies to obtain and select appropriate published literature references, preparation of summaries, use of previous agency findings of safety and effectiveness, and the potential pitfalls in using published literature findings and agency findings.

505(b)(2) Submissions: Eligibility, Strategies & Preparation is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, October 27, 2009. For more details, or to register please visit our site at www.fxconferences.com