PDUFA Calendar - Upcoming FDA Decisions
25 upcoming FDA target action dates from SEC 8-K filings
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the target date by which the FDA commits to making a decision on a drug application (NDA or BLA). These dates are set when the FDA accepts a drug application for review.
- Standard Review: 10 months from submission acceptance
- Priority Review: 6 months from submission acceptance
- Outcome: Approval, Complete Response Letter (CRL), or extension
Data Source: SEC 8-K Filings
PDUFA dates are extracted from company SEC 8-K filings where companies announce FDA acceptance of their drug applications. This provides authentic, primary-source data directly from regulatory filings.
Last updated: March 11, 2026
Upcoming PDUFA Dates by Month
March 2026
April 2026
May 2026
June 2026
July 2026
August 2026
September 2026
October 2026
November 2026
December 2026
Recent Decisions (Last 6 Months)
26 PDUFA dates that have passed. Check company filings for approval/CRL outcomes.
March 2026
February 2026
January 2026
December 2025
November 2025
October 2025
Data Collection Methodology
- Search SEC EDGAR for 8-K filings containing "PDUFA"
- Extract PDUFA target dates using pattern matching
- Parse drug names from filing context where available
- Deduplicate by company (keeping most recent filing)
Limitations: Not all companies file 8-Ks announcing PDUFA dates. Some dates may be from historical context in filings. Drug names may not always be extractable.