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.

This audio conference covers:

• Drug products that can be submitted under 505(b)(2)
• Approaches for obtaining FDA and literature findings
• Strategies for use of FDA and literature findings
• How to prepare a 505(b)(2) submission
• Strategies for clinical and nonclinical bridging studies

About the speaker:

Howard Hubbell, PhD, is President of Hubbell Consulting, LLC (www.hubbell-consulting.com), a regulatory and clinical consulting firm with expertise in regulatory and medical writing. Dr. Hubbell has over 21 years of consulting experience in the pharmaceutical industry. He also has extensive experience in academia, spending 13 years as faculty in oncology and biochemistry at Hahnemann Medical School. Dr. Hubbell obtained his doctorate in cell and molecular biology at the University of Texas Graduate School of Biomedical Sciences at Houston.

Who should attend?

• Regulatory Affairs Managers
• Clinical Affairs & Operations Managers
• Project Managers
• Toxicologists
• Executive Management