What US Food and Drug Administration Modernization Act of 1997 (Public Law 105-115) - FDA Statutory Reform requires
The Food and Drug Administration Modernization Act of 1997 reauthorised the Prescription Drug User Fee Act, created an accelerated approval pathway for drugs treating serious or life-threatening conditions, codified the fast track designation, authorised dissemination of peer-reviewed information on unapproved uses under specified conditions, established a database of clinical trials for serious or life-threatening diseases that became ClinicalTrials.gov, allowed expanded access for individual patients to investigational drugs, restructured medical device approval pathways, allowed manufacturers to use national consensus standards in 510(k) submissions, and required FDA to issue good guidance practices regulations.
Pillar: Pharmaceuticals & Life Sciences · Authority: United States Congress (Government Publishing Office) · Version: 1.0.0 · Last updated:
Primary source: https://www.govinfo.gov/content/pkg/PLAW-105publ115/html/PLAW-105publ115.htm
SHA-256 integrity: c5f141657a4bd6eb9ceeeda3f37c8c357b4e9ce9ad0f847583856c6a4a7b0d8a
Primary Citations — 8 traced to source
- Public Law 105-115 FDA Modernization Act enacted November 21, 1997 https://www.govinfo.gov/app/details/PLAW-105publ115
- United States Government Publishing Office enrolled text https://www.govinfo.gov/content/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf
+ 6 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/us-fda-modernization-act-1997-pl-105-115.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/us-fda-modernization-act-1997-pl-105-115.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/us-fda-modernization-act-1997-pl-105-115
- Back to registry: Browse all 10,085 compliance nodes