Submission Times
The following transaction times are generated quarterly based on PDUFA submissions. Your company submission times may be above or below these transaction averages, sometimes by a significant amount. 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 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 | 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 | 0.05 GB | 11 sec | 16 sec | 12 sec | 3 mins | 11 mins | 14 mins |
| 1 GB to 5 GB | 3.2 GB | 10 mins | 16 mins | 24 mins | 15 mins | 18 mins | 1.1 hrs | |
| 5 GB to 10 GB | 8.92 GB | 16 mins | 37 mins | 1.1 hrs | 19 mins | 10 mins | 2.8 hrs | |
| 10 GB to 20 GB | 16 GB | 19 mins | 37 mins | 1.5 hrs | 19 mins | 18 mins | 3.1 hrs | |
| 20 GB to 30 GB | 19.1 GB | 23 mins | 34 mins | 1.7 hrs | 17 mins | 18 mins | 3 hrs | |
| 30 GB to 40 GB | No Data Available | |||||||
| DMF | Up to 1 GB | 0.06 GB | 18 sec | 8 sec | 8 mins | 3 mins | 11 mins | 22 mins |
| 1 GB to 5 GB | 1.45 GB | 2 mins | 2 mins | 6 mins | 8 mins | 37 mins | 55 mins | |
| 5 GB to 10 GB | 7.28 GB | 34 mins | 33 mins | 53 mins | 13 mins | 7 mins | 2.2 hrs | |
| 10 GB to 20 GB | No Data Available | |||||||
| 20 GB to 30 GB | ||||||||
| 30 GB to 40 GB | ||||||||
| NDA | Up to 1 GB | 0.07 GB | 17 sec | 20 sec | 1 min | 7 mins | 8 mins | 17 mins |
| 1 GB to 5 GB | 4.21 GB | 11 mins | 8 mins | 19 mins | 11 mins | 11 mins | 1 hr | |
| 5 GB to 10 GB | 7.28 GB | 34 mins | 33 mins | 53 mins | 13 mins | 7 mins | 2.2 hrs | |
| 10 GB to 20 GB | 14.32 GB | 1.2 hrs | 58 mins | 1.3 hrs | 28 mins | 25 mins | 4.5 hrs | |
| 20 GB to 30 GB | 29.97 GB | 23 mins | 11 mins | 1.3 hrs | 27 mins | 7 mins | 2.5 hrs | |
| 30 GB to 40 GB | No Data Available | |||||||
| 40 GB to 100 GB | 61.67 GB | 4.2 hrs | 1.8 hrs | 1.3 hrs | 5.8 hrs | 7 hrs | 19.3 hrs | |
| 100 GB and Above | 118.0 GB | 8.8 hrs | 18.3 hrs | 2.3 hrs | 1.2 hrs | 9.1 hrs | 39.4 hrs | |
| Non-Business Hours Submissions | ||||||||
| Application Type | Submission Size Range | 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 | 0.11 GB | 2 sec | 25 sec | 29 sec | 8 mins | 15 mins | 26 mins |
| 1 GB to 5 GB | 4.96 GB | 7 mins | 14 mins | 33 mins | 12 mins | 9 mins | 1.2 hrs | |
| 5 GB to 10 GB | 9.67 GB | 17 mins | 36 mins | 1.1 hrs | 25 mins | 8 mins | 2.9 hrs | |
| 10 GB to 20 GB | 12 GB | 29 mins | 1.1 hrs | 1.2 hrs | 30 mins | 10 mins | 3.6 hrs | |
| 20 GB to 30 GB | 26.0 GB | 7.2 hrs | 48 mins | 24 mins | 45 mins | 16 mins | 9.6 hrs | |
| 30 GB to 40 GB | No Data Available | |||||||
| DMF | Up to 1 GB | 0.06 GB | 2 mins | 7 sec | 21 sec | 8 mins | 20 mins | 22 mins |
| 1 GB to 5 GB | 1.14 GB | 2 mins | 3 mins | 5 mins | 8 mins | 15 mins | 33 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 | 0.05 GB | 27 sec | 20 sec | 33 sec | 7 mins | 15 mins | 23 mins |
| 1 GB to 5 GB | 4.13 GB | 27 mins | 24 mins | 41 mins | 16 mins | 11 mins | 2 hrs | |
| 5 GB to 10 GB | 7.6 GB | 14 mins | 16 mins | 44 mins | 11 mins | 4 mins | 1.6 hrs | |
| 10 GB to 20 GB | 12.45 GB | 8.2 hrs | 15 mins | 16 mins | 50 mins | 15 mins | 9.8 hrs | |
| 20 GB to 30 GB | 23.03 GB | 2.4 hrs | 28 mins | 30 mins | 1.8 hrs | 23 mins | 5.5 hrs | |
| 30 GB to 40 GB | No Data Available | |||||||
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 CFT inboxes
- Delivery Ack2 to User: Time it takes to unpackage submission, generate Ack2, and send Ack 2 back
- Delivery Ack3 to User: Time it takes to validate, generate Ack3, and send Ack 3 back
- N/A: Data not available