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.

This audio conference covers:

• Definitions that delineate when you can use either the 505(j) or 505(b)(2) strategy
• A clear understanding of FDA expectations for each type of submission
• Background knowledge to effectively gather required information and plan for each strategy
• The benefits of the different submissions (time, cost & exclusivity)

About the speakers:

Nick Fleischer, R.Ph., Ph.D., has 36 years of experience in biopharmaceutics, pharmacokinetics, pharmacy and clinical pharmacology. Dr. Fleischer advises clients and serves as an expert on intellectual property issues, including allegations related to patent infringement and validity. His career includes several positions at the United States Food and Drug Administration (FDA), the most recent being Director of the Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER).

Joel Falk has 35 years of experience in the pharmaceutical industry performing a variety of functions including medical writing, clinical development, design and monitoring, project management, strategic and portfolio management, and due diligence of products and companies. He has responsibility for the management of clinical research, data management, pharmacovigilance and pharmaceutical product defense issues. Mr. Falk has either led or been instrumental in more than 20 major drug submissions in the United States and abroad in a variety of therapeutic areas, as well as medical devices.

Who should attend?

• Regulatory Affairs
• Clinical Directors/Managers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.