What Prescription Drug User Fee Amendments requires
The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect user fees from persons submitting certain human drug applications for review or named as sponsors in approved applications…
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Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.1 · Last updated:
Primary source: https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments
SHA-256 integrity: 6e68fddbb3665830d1834a38e120aad1faa3c3e7a5edd4b1e67ce341ac8d542b
Primary Citations — 5 traced to source
- Prescription Drug User Fee Amendments - Application Fees: A human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval is assessed a full application fee.
- Prescription Drug User Fee Amendments - Application Fees: A human drug application for which clinical data with respect to safety or effectiveness are not required for approval is assessed one-half of a full fee.
+ 3 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-pdufa-prescription-drug-user-fee-act.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/us-pdufa-prescription-drug-user-fee-act.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/us-pdufa-prescription-drug-user-fee-act
- Back to registry: Browse all 10,102 compliance nodes