Submission Times
The following table reports quarterly average transaction times for PDUFA submissions. The Upload Duration column represents the average for all companies that have submitted PDUFA submissions this period, your company may be above or below these averages. There are a number of factors that affect submission upload and processing times. Below are some of these factors:
- Internet connection bandwidth: The bandwidth your Internet Service Provider (ISP) provides to your company
- Internet connection bandwidth consumption: The amount of available bandwidth is currently in use by the company. Upload speed can be determined by going to: https://www.speedtest.net/
- End client/user infrastructure: Capacity of end user's machine (processor and memory), network storage performance, and shared vs dedicated machine might also affect the speed of signing the submission and upload
- Uploading a submission during infrastructure maintenance (end user's and/or FDA)
- Submission traffic during the specific period: Multiple, very large submissions (e.g., over 10 GB) being received concurrently, then the ACK times will vary.
The numbers are averages across all submissions of the type and submission size range. Total submission count provides a context for how reliable the average might be. If there are too few submissions in a category, under or over performing outliers will greatly impact the reliability of the average. The targets for each processing phase are based on a 30 GB submission. View the targets in the column headings below.
| Business Hours Submissions | |||||||||
| Application Type | Submission Size Range | Total Submission Count | Avg Submission Size (compressed) | Upload Duration (Avg; Target: 6 Hrs) | Deliver Receipt to User (Avg; Target: 2 Hrs) | Delivery to Centers (Avg; Target: 2 Hrs 55 Mins) | Delivery Ack2 to User (Avg; Target: 5 Mins) | Delivery Ack3 to User (Avg; Target: 1 Hrs) | Total Duration (Avg; Target: 12 Hrs) |
| BLA | Up to 1 GB | 7,670 | 0.04 GB | 3 mins | 5 mins | 1 min | 0.1 min | 32 mins | 41 mins |
| 1 GB to 5 GB | 119 | 1.80 GB | 10 mins | 7 mins | 4 mins | 0.1 min | 18 mins | 39 mins | |
| 5 GB to 10 GB | 6 | 6.34 GB | 15 mins | 26 mins | 11 mins | 0.1 min | 2.6 hrs | 3.5 hrs | |
| 10 GB to 20 GB | 2 | 11.90 GB | 32 mins | 6 mins | 1.2 hrs | 0.1 min | 17 mins | 2.1 hrs | |
| 20 GB to 30 GB | 3 | 22.57 GB | 37 mins | 28 mins | 51 mins | 0.1 min | 26 mins | 2.4 hrs | |
30 GB to 40 GB | 1 | 31.07 GB | 1.4 hrs | 31 mins | 30 mins | 0.1 min | 17 mins | 2.7 hrs | |
40 GB to 100 GB | No Data Available | ||||||||
| 100 GB and Above | |||||||||
| DMF | Up to 1 GB | 3,730 | 0.03 GB | 7 mins | 8 mins | 1 min | 0.1 min | 1 hr | 1.3 hrs |
| 1 GB to 5 GB | 30 | 1.38 GB | 12 mins | 7 mins | 3 mins | 0.1 min | 13 mins | 35 mins | |
| 5 GB to 10 GB | No Data Available | ||||||||
| 10 GB to 20 GB | |||||||||
| 20 GB to 30 GB | |||||||||
| 30 GB to 40 GB | |||||||||
| NDA | Up to 1 GB | 13,081 | 0.04 GB | 3 mins | 5 mins | 1 min | 0.1 min | 24 mins | 34 mins |
| 1 GB to 5 GB | 194 | 2.02 GB | 10 mins | 6 mins | 5 mins | 0.1 min | 1.7 hrs | 2 hrs | |
| 5 GB to 10 GB | 18 | 6.76 GB | 19 mins | 17 mins | 28 mins | 0.1 min | 22 mins | 1.4 hrs | |
| 10 GB to 20 GB | 6 | 12.95 GB | 25 mins | 10 mins | 44 mins | 0.1 min | 12 mins | 1.5 hrs | |
| 20 GB to 30 GB | 6 | 21.77 GB | 46 mins | 39 mins | 34 mins | 0.1 min | 15 mins | 2.2 hrs | |
| 30 GB to 40 GB | 1 | 28.90 GB | 1.2 hrs | 43 mins | 43 mins | 0.1 min | 2 hrs | 4.7 hrs | |
| 40 GB to 50 GB | No Data Available | ||||||||
| 50 GB to 100 GB | |||||||||
| 100 GB and Above | |||||||||
| Non-Business Hours Submissions | |||||||||
| Application Type | Submission Size Range | Total Submission Count | Avg Submission Size (compressed) | Upload Duration (Avg; Target: 6 Hrs) | Deliver Receipt to User (Avg; Target: 2 Hrs) | Delivery to Centers (Avg; Target: 2 Hrs 55 Mins) | Delivery Ack2 to User (Avg; Target: 5 Mins) | Delivery Ack3 to User (Avg; Target: 1 Hrs) | Total Duration (Avg; Target: 12 Hrs) |
| BLA | Up to 1 GB | 3,323 | 0.04 GB | 3 mins | 3 mins | 1 min | 0.1 min | 35 mins | 41 mins |
| 1 GB to 5 GB | 52 | 1.91 GB | 9 mins | 4 mins | 5 mins | 0.1 min | 19 mins | 36 mins | |
| 5 GB to 10 GB | 2 | 8.57 GB | 24 mins | 8 mins | 1.2 hrs | 0.1 min | 13 mins | 1.9 hrs | |
| 10 GB to 20 GB | 1 | 10.64 GB | 29 mins | 1 min | 1.9 hrs | 0.1 min | 7 hrs | 9.5 hrs | |
| 20 GB to 30 GB | No Data Available | ||||||||
| 30 GB to 40 GB | 1 | 31.40 GB | 46 mins | 34 mins | 1.2 hrs | 0.1 min | 18 mins | 2.8 hrs | |
40 GB to 100 GB | No Data Available | ||||||||
| 100 GB and Above | |||||||||
| DMF | Up to 1 GB | 3,619 | 0.04 GB | 5 mins | 4 mins | 1 min | 0.1 min | 1.3 hrs | 1.4 hrs |
| 1 GB to 5 GB | 10 | 1.34 GB | 14 mins | 6 mins | 3 mins | 0.1 min | 1.3 hrs | 1.6 hrs | |
| 5 GB to 10 GB | No Data Available | ||||||||
| 10 GB to 20 GB | |||||||||
| 20 GB to 30 GB | |||||||||
| 30 GB to 40 GB | |||||||||
| NDA | Up to 1 GB | 3,676 | 0.04 GB | 2 mins | 2 mins | 2 mins | 0.1 min | 29 mins | 35 mins |
| 1 GB to 5 GB | 93 | 1.90 GB | 6 mins | 2 mins | 8 mins | 0.1 min | 1.1 hrs | 1.4 hrs | |
| 5 GB to 10 GB | 9 | 6.81 GB | 17 mins | 17 mins | 39 mins | 0.1 min | 32 mins | 1.8 hrs | |
| 10 GB to 20 GB | 3 | 13.50 GB | 20 mins | 8 mins | 21 mins | 0.1 min | 1.3 hrs | 2.1 hrs | |
| 20 GB to 30 GB | 2 | 20.93 GB | 1.4 hrs | 37 mins | 1.3 hrs | 0.1 min | 12 mins | 3.5 hrs | |
| 30 GB to 40 GB | No Data Available | ||||||||
40 GB to 50 GB | |||||||||
50 GB to 100 GB | |||||||||
Terminology
- Upload Submission Duration: How long does it take to upload a submission from my computer
- Deliver Receipt to User: When should I expect a receipt
- Delivery to Centers: How long does it take to deliver to Center inboxes
- Delivery Ack2 to User: Time it takes to unpackage submission, generate Ack2, and send Ack2 back
- Delivery Ack3 to User: Time it takes for the Center to validate the package, generate Ack3, and send Ack3 back
- N/A: Data not available