FDA Regulation of Combination Products

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FDA Regulation of Combination Products
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Speaker Profile

• Thomas E. Colonna earned a bachelor of science in
  microbiology from the University of Sciences in
  Philadelphia (formerly the Philadelphia College
  of Pharmacy and Science), a Ph.D. in molecular
  biology from the Johns Hopkins University, and a
  law degree from the Georgetown University Law
  Center. In addition, Dr. Colonna holds academic
  appointments at Johns Hopkins University and the
  University of Sciences in Philadelphia. Dr.
  Colonna provides consulting services in the
  scientific and regulatory aspects of a wide range
  of medical devices and biologics with particular
  expertise in the areas of in vitro diagnostics
  (ELISA-based, PCR-based, SNPs, microarrays, and
  pharmacogenomics), medical device software
  (including bioinformatics), and
  biotechnology-based products. Dr. Colonnas
  consulting clients range from Fortune 500
  companies to small start-up companies located
  throughout the US, as well as, Canada, India, and
  Russia. Widely published in numerous fields, Dr.
  Colonna brings a unique multidisciplinary
  approach to problem solving.

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Overview

• Overview A combination product is a product
  composed of any combination of a drug and a
  device a biological product and a device a drug
  and a biological product or a drug, device, and
  a biological product. Combination products are
  therapeutic and diagnostic products that combine
  drugs, devices, and/or biological products. FDA
  expects to receive large numbers of combination
  products for review as technological advances
  continue to merge product types and blur the
  historical lines of separation between FDAs
  medical product centers, which are made up of the
  Center for Biologics Evaluation and Research
  (CBER), the Center for Drug Evaluation and
  Research (CDER), and the Center for Devices and
  Radiological Health (CDRH). 

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Areas Covered in the Session

• Definition of combination product
• FDA Regulatory Pathways
• Primary Mode of Action
• User Fees

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