S 830 · 105th Congress · Health
Food and Drug Administration Modernization Act of 1997
Bill Progress
1
Introduced✓
Committee3
Senate Vote4
House✓
EnactedLatest: Became Public Law No: 105-115.(1997-11-21)
Plain Language Summary
[AI summary unavailable — showing source text]
TABLE OF CONTENTS: Title I: Improving Patient Access Title II: Increasing Access to Expertise and Resources Title III: Improving Collaboration and Communication Title IV: Improving Certainty and Clarity of Rules Title V: Improving Accountability Title VI: Increasing Resources by Setting Priorities Title VII: Fees Relating to Drugs Title VIII: Miscellaneous Food and Drug Administration Modernization and Accountability Act of 1997 - Title I: Improving Patient Access - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth a Food and Drug Administration (FDA) mission statement. (Sec. 102) Authorizes any person, through a licensed practitioner, to request, and any manufacturer or distributor to provide, an investigational drug, biological product, or device for the diagnosis, monitoring, or treatment of a serious condition (or any other condition designated by the Secretary of Health and Human Services) if specified requirements are met. (Sec. 103) Modifies effectiveness exception requirements for devices relating to conditions that affect fewer than 4,000 individuals in the United States. Title II: Increasing Access to Expertise and Resources - Mandates programs and polic…
Summarized by Claude AI · Non-partisan · For informational purposes only
CBO Cost Estimate
Congressional Budget OfficeS. 830, The Food and Drug Administration Modernization Act of 1997
Dec 30, 1997S. 830, The Food and Drug Administration Modernization Act of 1997
Full CBO report ↗Official non-partisan budget analysis by the Congressional Budget Office
Cosponsors (7)
2 Democrats5 Republicans