PRODUCT DEVELOPMENT USING THE NDA 505(b)(2) PATHWAY

The annual 505(b)(2) Forum will discuss the FDA NDA 505(b)(2) approval process and ideal approaches, key regulatory updates, recent court cases and successful approaches for 505(b)(2) development.

The interest in pursuing the 505(b)(2) pathway for NDA approvals is increasing, given:

  • The potential to reduce overall development time and costs by eliminating most nonclinical studies and extensive safety and efficacy tests by referencing existing data.
  • The incentive of market exclusivity for up to seven years.

The range of ideal product candidates is vast and can include changes in dosage form, strength, formulation or route of administration as well as new combination products.

Despite the increasing percentage of new small molecule drugs being approved under the 505(b)(2) process, the pathway may be viewed as complex for companies historically focused on “traditional” pathways, e.g., NDA 505(b)(1) or ANDA 505(j). Significant changes in small molecule development and in the generics market present a growing need for strategies in 505(b)(2) development.

The forum will cover:

  • Key factors in identifying a viable 505(b)(2) candidate
  • FDA guidelines covering the 505(b)(2) pathway and recent changes
  • Common mistakes associated with 505(b)(2) filings
  • Examples of successful 505(b)(2) applications including fixed dose combinations, improved drug absorption and altered route of administration
  • Recent FDA regulations and court cases

Intro

Moderator:

Ken Phelps, president and CEO, Camargo Pharmaceutical Services

Case Study 1 imageAN OVERVIEW OF THE 505(b)(2) PATHWAY AND IDEAL APPROACHES, INCLUDING RELEVANT CASE STUDIES

Presenter:

Ken Phelps, president and CEO, Camargo Pharmaceutical Services

Case Study 2 imagePRODUCT DEVELOPMENT USING NEW FORMULATIONS FOR THE 505(b)(2) PATHWAY (CASE STUDIES)

Presenter:

Ed Jule, Ph.D., senior manager, pharmaceutical development, Capsugel Dosage Form Solutions

Case Study 3 imageTASTE-MASKING FOR EFFECTIVE PEDIATRIC FORMULATIONS

Presenter:

Ed Jule, Ph.D., senior manager, pharmaceutical development, Capsugel Dosage Form Solutions

Case Study 4 imageTHE CHANGING LANDSCAPE OF 505(b)(2) AND RECENT COURT DECISIONS

Presenter:

Kurt Karst, J.D., director, Hyman, Phelps & McNamara, PC

Read summary

Summary:

Controversies concerning 505(b)(2) applications are on the rise! During this session we will discuss two recent court cases concerning important 505(b)(2) issues, including choice of Listed Drug and the scope of 3-year exclusivity under the Hatch-Waxman Amendments.

Download the Full Presentation Slides

Host Companies

CamargoCapsugel

About The 505(b)(2) Forum

The 505(b)(2) Forum was organized by product developers and service providers interested in improving best practices across the 505(b)(2) development process.