{
  "id": "98-263",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "98-263",
  "active": false,
  "source": "EveryCRSReport.com",
  "versions": [
    {
      "source": "EveryCRSReport.com",
      "id": 330006,
      "date": "1998-03-13",
      "retrieved": "2016-05-24T20:55:41.120941",
      "title": "Food and Drug Administration Modernization Act of 1997 - The Provisions",
      "summary": "The Food and Drug Administration Modernization Act of 1997,  P.L. 105-115 , is the first\ncomprehensive revision of the Nation's food, drug, and medical device laws in 30 years. This statute\nestablishes new standards for product review and regulatory approval under the Federal Food, Drug,\nand Cosmetic Act and the Public Health Service Act. Several of the changes made by the new law\ncodify regulatory initiatives undertaken previously by the Food and Drug Administration.\n Title I deals with various drug regulatory concerns. Key provisions include a five-year\nreauthorization of the Prescription Drug User Fee Act allowing the agency to charge manufacturers\nfees to facilitate the review of new drugs and biological products. Manufacturers who conduct\nadditional studies to enhance pediatric labeling for products will qualify for six months additional\nmarketing exclusivity, and drugs to treat life-threatening conditions will be given fast track\nconsideration. In addition, drug approval norms will be eased by reducing the number of clinical\ninvestigations needed and granting manufacturers the latitude to submit abbreviated study reports.\nAgency guidance documents will be issued to streamline the drug review process and provide a\nmeans for resolving controversial scientific issues. \n Requirements for medical device approval and postmarket surveillance are addressed in Title\nII. The measure seeks to improve the premarket review process by requiring clarity, timeliness, and\nbetter communication between the FDA and regulated industry. Regulatory issues addressed include\ninvestigational device exemptions, premarket notification, special review, humanitarian uses of\ndevices, device standards, data requirements, classification, and development protocols. Moreover,\na third-party review program is established to expedite the review of certain Class I and II devices. \nRegulatory requirements are reduced for such postmarket activities as tracking, surveillance, and\nreporting.\n Title III addresses several food regulation issues. It allows expedited procedures for the use of\nnew nutrient content and health claims and specifies timely action on claims petitions. It also allows\nnutrient content and health claims to be made based on authoritative statements issued as current\npolicy of relevant scientific agencies. The Act amends the food irradiation provisions to prohibit\nlabeling requirements that are more prominent than the ingredient listing, and it requires a timely\ndecision on review of the pending red meat irradiation petition. Further, the law establishes a\nnotification system for food contact substances. \n Title IV permits the dissemination of information about \"off-label\" uses of drugs or devices not\nyet approved by the FDA. Other provisions allow patients expanded access to investigational\ntherapies, encourage international harmonization agreements, and establish national uniformity in\nthe regulation of nonprescription drugs and cosmetics. For the first time, the FDA must conduct its\nregulatory functions under a mission statement that will obligate it to maintain a public health\nprotection role while seeking to expedite the marketing of regulated products.",
      "type": "CRS Report",
      "typeId": "REPORTS",
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      "topics": []
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  ],
  "topics": [
    "American Law",
    "Environmental Policy"
  ]
}