Webinar on FDA Expectations from 505(b)(2) Product Development Pathway

Description :

A 505(b)(2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. It involves making significant changes to an existing FDA approved product, called reference product, to create a new product with its own indication, formulation, population, and/ or other differences that need to be supported with clinical studies. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for a previously approved drug, thereby reducing the number of clinical trials required for approval. The biggest incentive to develop 505(b)(2) products is 3 years of market exclusivity available to the approved product.

This seminar will discuss the practical strategies for drug development via 505(b)(2) regulatory pathway. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of interactions with the FDA, global clinical trials, market access, reimbursement issues and projected trends for the near future. Lastly, the 505(b)(2) pathway will be compared to that for biosimilars.

Areas Covered in the Session :

The 505(B)(2) regulation and guidance from the FDA

Strategic considerations before embarking on a 505(b)(2) development project

Intellectual property issues with such products

Key development steps for such products

FDA’s review process and ongoing consultation

Challenges to developing 505(b)(2) product and possible solutions

Examples of successful strategies for developing such products

Searching for a 505(b)(2) project, future trends

505(b)(2) and biosimilars

Speaker's PASS-IT Recommendations

Who Will Benefit:

CEOs

VPs

Compliance Officers

Attorneys

Regulatory Affairs

Clinical Affairs

Quality Assurance

Research & Development

Project Managers

Consultants

Contractors/Subcontractors