Statements and Testimony - 1999

  • September 22, 1999 - FDA Guidance Document on Labeling for Laboratory Tests
    The ASM submitted comments on the Food and Drug Administration's draft guidance document on labeling for laboratory tests. This guidance proposes that labeling reflect a dichotomy based on the types of study done when a device is being characterized for marketing. FDA's motivation for this guidance is their concern that the terms "relative" or "comparative" sensitivity and specificty are misleading and imply diagnostic performance that is different from that supported by many premarket studies.
  • May 27, 1999 - Animal Welfare Act
    The ASM responded to a request for comments on a petition which would require the USDA to amend the definition of "animal" under the Animal Welfare Act regulations to include rats and mice bred for research and birds.
  • March 17, 1999 - ASM Response to OMB Circular A-110
    The ASM sent a letter to Mr. F. James Charney of the Office of Management and Budget (OMB) in response to OMB Circular A-110 "Uniform Administration Requirements for Grants and Documents with Institutions of Higher Education, Hospitals and Other Nonprofit Organizations."