New Rules for FDA Regulation of Lab Developed Diagnostic Tests (LDT)

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• New Rules for FDA Regulation of Lab Developed
  Diagnostic Tests (LDT)

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• The questionable assay was a
  laboratory-developed test, which means vitro
  diagnostic test that is designed, manufactured,
  and used within a single laboratory.
  Laboratory-developed tests exist in a regulatory
  crevice. Because of its broad statutory authority
  over products intended for use in the diagnosis
  of disease or other conditions, the FDA considers
  laboratory-developed tests under its
  jurisdiction.
• Recently, however, the FDA has expressed
  concern with the proliferation of
  laboratory-developed tests, their marketing, and
  their potential to mislead physicians and
  patients and undermine clinical care. On July 31,
  2014, the agency notified Congress that the
  agency would shortly release a draft guidance
  document containing a framework for the
  application of agency standards for quality,
  safety, and validity to laboratory-developed
  tests.

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• On September 30, the
  agency posted the draft guidance document to its
  website and opened a comment period lasting until
  February 2, 2015. The agency will hold a public
  meeting on the topic on January 8 and 9, 2015, at
  the National Institutes of Health in Bethesda,
  Maryland.
• In this webinar speaker Mukesh Kumar
  speaks about updated FDA rules and regulations of
  Lab Development Diagnostic Tests and labeling,
  marketing practices.
• This webinar will discuss the current
  rules and practical tips for being compliant. The
  instructor will also provide advice based on his
  extensive regulatory experience on the best and
  worst case scenarios for various kinds of LDTs
  under the current regulations. The presentation
  is intended for general instructions to all LDT
  providers such as laboratories, clinics,
  physicians, hospitals, reimbursement experts,
  clinical trial users, and regulators who wish to
  have a better understanding of how FDA intends to
  regulate LDTs. 

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• Instructor Profile
• Mukesh Kumar, leads the
  Regulatory Affairs and Quality Assurance
  departments at Amarex Clinical Research, a full
  service CRO based in Germantown, MD. His key
  expertise is in developing Global Regulatory
  Business Strategies for biomedical product
  development and his passion is to bring
  traditional therapies for India, China and the
  Latin-America to the Western markets. In addition
  to regulatory expertise, Mukesh is an experienced
  auditor and a trainer in regulatory and business
  processes.Mukesh started his professional
  career as a research scientist at the NIH, Baylor
  College of Medicine, Houston, and several premier
  institutions in India. With more than 11 years of
  experience in virology, gene therapy, and
  molecular biology, Mukesh has expertise in
  biological and combination products. He has been
  a global Regulatory Affairs Specialist (US, EU,
  and India) for the last 5 years.

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• Who can Benefit
• Senior management of LDT providers
• Project Managers
• Regulatory Vice Presidents, Directors and
  Managers
• Lab testing professionals
• Compliance professionals
• Auditors
• Attorneys - In-house or Outside Counsel

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• Live Session - How it works
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf formate will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Get certification of attendance.
• Recorded Session - How it works
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf formate will be
  mailed to you
• Get certification of attendance.

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