Other terms
- Protocol
- Protocol Amendments
- Protocol Deviations
- Prurigo Nodularis
- Pruritus
- Psoriasis
- Quality Assurance (QA)
- Quality Control (QC)
- Query
- Randomization
- Real-World Data
- RECIST
PDUFA
PDUFA (PDUFA date)
When a clinical trial is completed and the FDA accepts the CSR, a “PDUFA date” is set 10 months from that date of acceptance.
Biotech companies will often release the “PDUFA date” to the general public for patients, patient advocacy groups and doctors to prepare for the potential approval.
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