FDA's Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Tue, Jun 14, 2016
Length
90 minutes
Product Description

Get to know about the U.S. FDA’s Draft Guidance on Transition Biological Products

 

The approach of FDA towards implementing the provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an application for a biological product that is approved on or before March 23, 2020, under Section 505 of the Federal Drug, Cosmetic and Food Act 20 (FD&C Act) (21 U.S.C. 355) would be “deemed to be a license” for biological products that comes under section 351 of the Public Health Service Act (PHS Act) on March 23, 2020. FDA’s interpretation of the “deemed to be a license” provision of the BPCI Act for biological products that have been or will be approved on or before March 23, 2020.

Join this session, with expert speaker John E. Lincoln, where he will analyze and take you through the U.S. FDA’s “Draft Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings”. John will analyze how the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) will be implemented by the agency and how it proposes to do it. There will be discussions on the moving of protein products that are currently under the drug statute to the biologics system.  The key March 23, 2020, deadline. What does being “deemed to be a license” mean for all new drug applications (NDAs) and abbreviated new drug applications (ANDAs) under section 351 of the Public Health Service Act (PHS Act)? How this draft explains for the first time FDA’s interpretation of the “deemed to be a license” provision.  The importance of “draft” to affected companies and their products.

Session Highlights:

  • The FDA’s draft Guidance on Transition Biological Products
  • How FDA will move approved protein products (under “drugs”) to “biologics”
  • Biosimilar
  • The March 23, 2020 deadline
  • New drug applications (NDAs) and abbreviated new drug applications (ANDAs) for protein products “deemed to be a license”
  • General patent issues
  • NDAs or ANDAs replaced by Biologics License Applications (BLAs)
  • Exclusivity and exclusivity termination

Who should attend?

  • Senior management in:
    • Drugs,
    • Devices,
    • Biologics,
    • BiosimilarsCombination products,
    • Dietary Supplements
  • QA
  • RA
  • Engineering
  • R&D
  • Marketing
  • Operations
  • Senior Management
  • Consultants; others tasked with product, process, validations, CGMP responsibilities
  • Useful for members of AQC, RAPS, AAMI, etc.

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

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About Our Speaker

John E. Lincoln


John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation...   More Info
More Events By The Speaker

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