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Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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B Glossary
Pages 222-227

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From page 222...
... Advisory Committee: A panel of outside experts convened periodically to advise the FDA on safety and efficacy issues about drugs and other FDAregulated products. The FDA is not bound to follow committee recommendations, but its decisions usually parallel the recommendations of its advisory committees.
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From page 223...
... Class m: A premarket approval class for devices that cannot be placed in either Class I or Class II. A device in this class has at least one of the following characteristics: it is purported for use in supporting or sustaining human life or for a use that is of substantial importance in preventing the impairment of human health; it presents a potentially unreasonable risk of illness or injurer, or it is a transitional device.
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From page 224...
... Effectiveness: In health care policy and clinical care, "effectiveness usually refers to the performance and evaluation of a health care technology in general clinical use. "Efflcapy,~ by contrast, is used to denote the use and evaluation of a health care technology under highly controlled conditions by unusually qualified practitioners.
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From page 225...
... Pre-Market Approval: The device manufacturer must provide reasonable assurance of safety and effectiveness under the conditions of intended use. Under the 1976 Medical Device Amendments, the FDA had to submit all pre-marketing approval applications to an advisory committee for a recommendation on the decision.
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From page 226...
... Safety Update Reports: Reports that an NDA sponsor must submit to the FDA about any new safety information that may affect the draft labeling statements about contraindications, warnings, precautions, and adverse reactions. Safety update reports are required four months after the application is submitted, after the applicant receives an approvable letter, and at other times upon the FDA's request.
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Key Terms

  • approvable letter
  • approved nda
  • care technology
  • clinical studies
  • safety update

  • approved drug
  • provide reasonable
  • drug application
  • adverse reactions
  • animals help

  • special requirements
  • controls plus
  • animal test
  • ingredient intended
  • human testing

  • shorter life
  • active ingredient
  • human life
  • previously approved
  • anda includes

  • establish boundaries
  • substantial importance
  • effectiveness usually
  • technical viewpoints
  • originally set

  • toxic effects
  • efficacy issues
  • safe medical
  • unreasonable risk
  • institutional review


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