Skip links

505(b)(2) Regulatory Planning: Designing Streamlined Programs to Create Value for Patients and Sponsors

Date: September 29, 2021

Presenters:
Cathy Gatza, PhD, VP of Regulatory and Strategy
Andrea Miller, Manager of Life Science Solutions


The 505(b)(2) pathway allows sponsors to develop new drugs by leveraging data from a diverse range of sources and establishing a bridge to data from a previously approved drug. When successful, the 505(b)(2) pathway enables sponsors to realize significant time and cost savings, often while carrying lower risk and preserving exclusivity benefits.

Sponsors can use the 505(b)(2) pathway to develop drugs with new indications, dosage forms or strengths, formulations, dosing regimens, routes of administration, or even active ingredients. In many cases, these changes create new, differentiated products that patients or healthcare providers prefer over previous versions, leading to both improved experiences for patients and tremendous commercial value for sponsors.

Register for this webinar to discover early planning best practices for building and executing a successful, streamlined 505(b)(2) development program and to hear a case study demonstrating how a product developed through this pathway can dramatically improve the patient journey.

This webinar will answer questions like:

  • What is the 505(b)(2) regulatory pathway?
  • What are the benefits and regulatory implications of the 505(b)(2) pathway?
  • How can a sponsor prepare and plan for a 505(b)(2) development program?
  • How can the 505(b)(2) pathway be leveraged to improve the patient journey?

Download the Webinar

  • This field is for validation purposes and should be left unchanged.