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Utilizing the 505(b)(2) Pathway to Streamline and Accelerate a Drug Development Plan

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Continuing Education credit or Certificate Program units are not available for Archived Webinars

In 2012, approximately 50 percent more products were approved through 505(b)(2) development compared to 505(b)(1) product approvals. The FDA’s 505(b)(2) approval pathway allows modification and repositioning of existing drugs or new chemical entities to provide products with improved safety and efficacy. However, you must understand the unique regulatory requirements and the best process to approach the FDA with your 505(b)(2) development plan. 

This webinar will illustrate how successful 505(b)(2) programs can be executed using preclinical studies to bridge to existing clinical data of an approved drug. The presentation reviewed currently approved 505(b)(2) drugs and the associated development plans that generated critical data to establish a nonclinical bridge between existing literature and data for the approved drug, as well as analytical and drug metabolism techniques that can be used for development.

In this webinar the presenter highlighted the following:

  • How metabolism studies can establish the appropriate species to build a toxicological bridge to existing data for an approved drug
  • How the dose response and equivalency of candidate products and the approved drug are evaluated
  • How a PIND meeting can be used to obtain FDA’s input regarding the appropriateness of the 505(b)(2) pathway and a proposed streamlined development plan

Archived Webinar available for purchase through May 1, 2014

Who Should Attend 

Professionals involved in:

  • RD – Research & Development
  • RA – Regulatory Affairs
  • OS – Outsourcing
  • NC – Nonclinical
  • CP – Clinical Safety/Pharmacovigilance
  • CR – Clinical Research

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Identify potential candidates for 505(b)(2) drug development
  • Discuss process needed to obtain FDA input regarding the appropriateness of a 505(b)(2) development plan
  • Describe nonclinical, drug metabolism techniques that can establish equivalency and differences between a candidate to be approved via the 505(b)(2) pathway and a comparison product
  • Discuss the benefits that may be achieved through a 505(b)(2) submission

Contact Information 

Questions on Archived Webinar
Jessica Culp
DIA North America
Phone +1.215.442.6132
Fax +1.215.442.6199

Technical Requirements 

Click here for minimum system requirements.


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Day 1 Monday, April 22, 2013

  • 7:00AM - 11:59PM

    Utilizing the 505(b)(2) Pathway to Streamline and Accelerate a Drug Development Plan


    • Kenneth Phelps
      President and Chief Executive Officer
      Camargo Pharmaceutical Services, LLC, United States

Registration Fees 

Other Fees

Government (Full Time) Individual
Charitable Nonprofit/Academia Individual
Group Site
Group Plus


Member Individual


NonMember Individual
Group Discounts

  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.

No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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