Product Development Using the NDA 505(b)(2) Approval Pathway

September 29, 2015 - 8:00am

Product Development Using the NDA 505(b)(2) Approval Pathway

The 505(b)(2) NDA pathway is increasingly utilized to bring improved and differentiated products to market faster and more cost effectively. 505(b)(2)  products often utilize enabling technologies to create better medicines through new formulations, new dosage forms, and new combinations which can result in up to 7 years of market exclusivity.

In this webinar

Camargo and Capsugel discuss 505(b)(2) challenges, recent regulatory updates, and case studies demonstrating successful application of enabling technologies in 505(b)(2) product development.

Presenters

Ken V. Phelps, President & CEO at Camargo Pharmaceutical Services

 

 

 

Trevor Wigle, Director of Product Development at Capsugel Dosage Form Solutions

 

 

 

 

View the presentation by clicking the play button in the video below.

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