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505(b)(2) Regulatory Planning: Designing Streamlined Programs to Create Value for Patients and Sponsors, Upcoming Webinar Hosted by Xtalks
Tuesday, September 21, 2021

In this free webinar, the featured speakers will explain what the 505(b)(2) regulatory pathway is and discuss its benefits and regulatory implications. Attendees will learn how a sponsor can prepare and plan for a 505(b)(2) development program and how the pathway can be leveraged to improve the patient journey.

TORONTO, Sept. 13, 2021 /PRNewswire-PRWeb/ -- 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.

Join expert speakers from Camargo, Cathy Gatza, PhD, VP of Regulatory and Strategy, and Andrea Miller, Manager of Life Science Solutions, in a live webinar on Wednesday, September 29, 2021 at 11am EDT (4pm BST/UK) 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.

For more information, or to register for this event, visit 505(b)(2) Regulatory Planning: Designing Streamlined Programs to Create Value for Patients and Sponsors.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit

For information about hosting a webinar visit

Media Contact

Sydney Perelmutter, Xtalks, +1 (416) 977-6555 x 352,


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