How to Best Use Regulatory Pathways: ANDA and 505(b)(2)

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Thu, Jul 27, 2017
60 minutes
Product Description

Learn about ANDA and 505(b)(2): The Regulatory Pathways of the Federal Food, Drug and Cosmetic Act

The United States Food and Drug Administration (FDA) approves news drugs and generic drugs under distinct regulatory pathways covered under Section 505 of the Federal Food, Drug and Cosmetic Act (FDCA or the Act). For firms to bring certain new and generic drug products into the US market, it is critical to understand how to best use the distinct regulatory pathways.

Join this session, where expert speaker David Lim, Ph.D., RAC, ASQ-CQA, will discuss the regulatory pathways, 505(b)2 for new drug applications (NDAs) and 505(j) for abbreviated new drug applications (ANDAs) and will give you a better understanding of the FDA’s regulatory pathways under sections of 505(b)2 and 505(j) of the FDCA. The session will provide you with a great opportunity to consider and use the regulatory pathways from practical and business perspectives. The session will further provide you with how to and practical tips as well as a great opportunity to help save your resources.

Session Highlights:

  • Applicable statute(s) and regulations
  • Definitions
  • 505(b)2 and 505(j) requirements
  • CMC requirements
  • Drug examples approved under 505(b)2 and 505(j)
  • Important considerations
  • PASS-IT recommendations: Best practices

Who Should Attend?

  • CEOs
  • VPs
  • Compliance officers
  • Attorneys
  • Regulatory affairs
  • Clinical affairs
  • Quality assurance
  • R&D
  • Consultants
  • Contractors/subcontractors
  • Anyone interested in the FDA regulatory pathways for new drugs and generics.

At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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