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: http://beta.speedtest.net
- Geographic proximity to FDA (Washington DC): The farther your location from FDA, the more network hops are required for your connection to reach FDA. The more hops your connection takes to get to FDA, the longer your submission will take to get to FDA
- Data compression ratio (for multi-file submissions) and submission composition: The number of files and folders/directories and the type of data you are sending will affect the speed at which the submission makes it to FDA
- 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