FDA Enforcement Overview Agency Overview FDA regulates > 20 of - - PowerPoint PPT Presentation

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FDA Enforcement Overview Agency Overview FDA regulates > 20 of - - PowerPoint PPT Presentation

Dec 14, 2022 292 likes •381 views

FDA Enforcement Overview Agency Overview FDA regulates > 20 of every $1 spent by U.S. consumers The Agency has enforcement roots Has the only federal law enforcement agency exclusively devoted to public health (OCI) 16,738

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SLIDE 1

FDA Enforcement Overview

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SLIDE 2

Agency Overview

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  • FDA regulates > 20¢ of every $1 spent by U.S.

consumers

  • The Agency has enforcement roots
  • Has the only federal law enforcement agency

exclusively devoted to public health (OCI)

  • 16,738 total employees (FY 2015 Budget

Justification)

CDRH: 1,723 ORA: 5,250 CDER: 4,508

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SLIDE 3

Product Types: Low-Hanging Fruit

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  • Software (e.g., mobile apps, cloud apps)
  • Miscellaneous consumer products

(e.g., “vision trainers”, “balance trainers”)

  • Dietary supplements
  • Food
  • Cosmetics
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SLIDE 4

Office of the Commissioner Office of Foods and Vet Med Office of Global Regulatory Operations and Policy Office of Medical Products and Tobacco

CFSAN CDRH CBER CTP CDER CVM ORA OCC

FDA Structure

Agency Overview

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SLIDE 5

Primary Enforcement Resources

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SLIDE 6

Primary Enforcement Resources

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SLIDE 7

Primary Enforcement Resources

Par Park Doct k Doctrine ne

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SLIDE 8

FDA Enforcement Overview