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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011) / Chapter Skim
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1 Introduction
Pages 11-16

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From page 11...
... THE FOOD AND DRUG ADMINISTRATION AND ITS CENTERS The modern regulatory functions of FDA date to 1906, when a law that banned interstate commerce in adulterated or misbranded foods and drugs was passed.1 Since then, over 200 laws have shaped the agency into what exists to 1 For a history of FDA and the laws that have shaped its development, see FDA 2010a.
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From page 12...
... FIGURE 1-1 Worldwide distribution of establishments regulated by the U.S. Food and Drug Administration.
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From page 13...
... Like the other centers, CDRH monitors postmarket problems through an adverse-events reporting database. THE COMMITTEE'S TASK AND DECISION SCENARIOS FROM THE FOOD AND DRUG ADMINISTRATION Given its vast responsibilities, its limited resources, and the difficult decisions that it faces daily, FDA recognized that a systematic approach to evaluating the risks associated with its products or product categories would be valuable.
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From page 14...
... For example, how should FDA balance potential concerns about product safety with the potential consequences of decreased product availability? Targeting decisions in which FDA must determine which among a broad array of product hazards or potential health benefits should be addressed to obtain the maximum public-health benefit.
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From page 15...
... As discussed in the recent report Enhancing Food Safety: The Role of the Food and Drug Administration, "risk decision making takes place in a broader social context" (IOM/NRC 2010, p.
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From page 16...
... FY 2011 Food and Drug Administration Congressional Justification [online]
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Key Terms

  • medical devices
  • manufacturing facilities
  • decision scenarios
  • veterinary products
  • veterinary drugs

  • fda product
  • ranking fda
  • ensure compliance
  • various centers
  • drugs require

  • adverse events
  • food supply
  • premarket approvals
  • require premarket
  • health consequences

  • administration congressional
  • potential health
  • evaluates data
  • events associated
  • consequences associated

  • congressional justification
  • categories based
  • emit radiation
  • product safety
  • regulates drug

  • ensure identity
  • cvm establishes
  • egg products
  • cdrh conducts
  • tobacco products


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