![[ICO]](/icons/blank.gif) | Name | Last modified | Size | Description |
|---|
|
|---|
![[PARENTDIR]](/icons/back.gif) | Parent Directory | | - | |
![[TXT]](/icons/text.gif) | Biologics License Application Filing Letter - BAT.txt | 2017-06-26 15:24 | 1.6K | |
![[ ]](/icons/layout.gif) | CMC Final Review - BAT.pdf | 2017-06-26 14:59 | 56K | |
| CMC Mid-cycle Review - BAT.pdf | 2017-06-26 15:00 | 96K | |
| Clinical Pharmacology Review, February 26, 2013 - BAT.pdf | 2017-06-26 13:43 | 1.9M | |
| Clinical Review Memo, December 20, 2012 - BAT .pdf | 2017-06-26 13:42 | 3.7M | |
| Committee Filing Memorandum - BAT.pdf | 2017-06-26 15:27 | 29K | |
| Final Revew Memo, Original BLA - BAT.pdf | 2017-06-26 14:28 | 333K | |
| Final Review Memo, March 22, 2013 - BAT.pdf | 2019-03-12 14:28 | 1.0M | |
| Final Review Memo, NHP Animal Studies - BAT.pdf | 2017-06-26 14:26 | 231K | |
| Final Review Process Validation Memo, March 7, 2013 - BAT.pdf | 2017-06-26 13:35 | 80K | |
| First Committee Meeting Summary, October 18, 2012 - BAT.txt | 2017-06-26 15:22 | 4.1K | |
| Important!!!! Clinical Review Memo, March 18, 2013.pdf | 2017-06-26 13:44 | 321K | |
| Information Request Letter, December 21, 2012 - BAT .pdf | 2017-06-26 15:15 | 73K | |
| Information Request Letter, December 31, 2012 - BAT.txt | 2017-06-26 15:13 | 2.8K | |
| Information Request Letter, November 20, 2012 - BAT.pdf | 2017-06-26 15:21 | 34K | |
| Information Request Letter, November 28, 2012 - BAT.txt | 2017-06-26 15:28 | 1.5K | |
| Mid-cycle Meeting Summary, December 12, 2012 - BAT.txt | 2017-06-26 15:16 | 6.2K | |
| Midcycle Toxicology Review Memo - BAT.pdf | 2017-06-26 14:56 | 59K | |
| Nonclinical Pharmacology Toxicology Memo - BAT.pdf | 2017-06-26 14:54 | 61K | |
| Officer- Employee List , March 8, 2013 - BAT.txt | 2017-06-26 15:04 | 645 | |
| PVP Review Memo, February 28, 2013 - BAT .pdf | 2017-06-26 13:36 | 228K | |
| Priority Review Memo, November 8, 2012 - BAT.pdf | 2017-06-26 13:48 | 44K | |
| Process Validation Midcycle Memo, December 19, 2012 - BAT.pdf | 2017-06-26 13:41 | 148K | |
| Proprietary Name Review Letter - BAT.txt | 2017-06-26 13:38 | 1.2K | |
| Record of Telephone Conversation, December 5, 2012 - BAT.txt | 2017-06-26 15:17 | 1.1K | |
| Record of Telephone Conversation, December 10, 2012 - BAT.txt | 2017-06-26 15:17 | 1.8K | |
| Record of Telephone Conversation, January 22, 2013 - BAT.txt | 2017-06-26 15:13 | 5.0K | |
| Record of Telephone Conversation, March 15, 2013 - BAT.txt | 2017-06-26 15:12 | 1.6K | |
| Stat Midcycle Review, December 7, 2012 - BAT .pdf | 2017-06-26 13:44 | 367K | |
| Statistical Review and Evaluation - BAT .pdf | 2017-06-26 14:32 | 373K | |
|
|---|