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505(b)(2) NDAs - Webinar

  • ID: 4899632
  • Webinar
  • March 2019
  • Region: Global
  • 120 Minutes
  • Compliance Online
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Why Should You Attend:

NDAs submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) are a those for which the product is not a generic nor a traditional brand. It allow sponsors to reference data that was not generated by them. This type of submission can shave years off of the development process and save millons of dollars. Attend this webinar to learn which products qualify for submissions under 505(b)(2), data that may be referenced, content requirements, and regulatory benefits.

Areas Covered in the Webinar:

What is a 505(b)(2) NDA
What products qualify for submission under 505(b)(2)
Examples of data and information that may be referenced
Requirements for studies to be conducted
Submission content requirements
Limitations to and benefits of a 505(b)(2)
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Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).
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