Appendix_E1_-_FAERSWeeklyStats2015_11_17.xls
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- 16-223-SOL-00101
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Appendix E Detailed Weekly Reports - file 1 of 3
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| File | Type | Posted |
|---|---|---|
| 16-223-SOL-00101_Q A_2.pdf | ||
| Attachment_C_pgs_20-21rev.pdf | ||
| 16-223-SOL-00101_QA.pdf | ||
| Appendix_A_-_facility.pdf | ||
| Appendix_B_-_ZIP-Approved_SOPs_033115.zip | ZIP file | |
| Appendix_C_-_courier_route_2016.docx | DOCX document | |
| Appendix_E3_-_SOP_Weekly_Reports.docx | DOCX document | |
| Appendix_F_-_Graphical_workflow_diagram.doc | DOC document | |
| Appendix_E2_-_DQRS2015_Stats.xls | XLS spreadsheet | |
| 16-223-SOL-00101_rev.pdf | ||
| Appendix_D_-_Final_DSI_May_2015_6_Month_Review_050615.pdf | ||
| Attachment_D.pdf | ||
| Attachment_G.pdf | ||
| Attachment_C.pdf | ||
| Attachment_E_-_Pricing_Worksheets.xls | XLS spreadsheet | |
| Attachment_J_WD_15-4281_(Rev.-3).pdf | ||
| Attachment_I_Form_FDA_3398_(10-10).pdf | ||
| Attachment_F.pdf | ||
| 16-223-SOL-00101.pdf | ||
| Attachment_A.pdf | ||
| Attachment_H.docx | DOCX document |
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PIPELINE
| PIPELINE | PIPELINE AGE RANGE | ||||
| DATA ENTRY | CODING | VALIDATION | |||
| DIRECT | 129 | 240 | 212 | DIRECT | 7 DAYS |
| EXPEDITED | 0 | 11 | 12 | EXPEDITED | 4 DAYS |
| PERIODIC | 1 | 6 | 4 | PERIODIC | 14 DAYS |
| EXPEDITED E2B | 48 | 112 | EXPEDITED E2B | 3 DAYS | |
| PERIODIC E2B | 177 | 16 | PERIODIC E2B | 11 DAYS | |
| TOTAL | 130 | 482 | 356 | ||
| GRAND TOTAL | 968 |
PENDING
| PENDING | ||||||||||||||||||||||||||||||||||||||||||||||
| 1/5/15 | 1/12/15 | 1/19/15 | 1/26/15 | 2/2/15 | 2/9/15 | 2/16/15 | 2/23/15 | 3/2/15 | 3/9/15 | 3/16/15 | 3/23/15 | 3/30/15 | 4/6/15 | 4/13/15 | 4/20/15 | 4/27/15 | 5/4/15 | 5/11/15 | 5/18/15 | 5/25/15 | 6/1/15 | 6/8/15 | 6/15/15 | 6/22/15 | 6/29/15 | 7/5/15 | 7/13/15 | 7/20/15 | 7/27/15 | 8/3/15 | 8/10/15 | 8/17/15 | 8/24/15 | 8/31/15 | 9/7/15 | 9/14/15 | 9/21/15 | 9/28/15 | 10/5/15 | 10/12/15 | 10/19/15 | 10/26/15 | 11/2/15 | 11/9/15 | 11/16/15 | |
| EXPEDITED INI | 18 | 85 | 96 | 212 | 0 | 88 | 98 | 429 | 209 | 207 | 166 | 38 | 0 | 0 | 0 | 7 | 0 | 94 | 61 | 0 | 0 | 77 | 17 | 36 | 57 | 34 | 21 | 0 | 20 | 28 | 0 | 0 | 60 | 0 | 5 | 12 | 25 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| EXPEDITED FU | 48 | 22 | 3 | 109 | 23 | 0 | 30 | 0 | 32 | 88 | 15 | 27 | 0 | 0 | 0 | 0 | 0 | 45 | 7 | 0 | 0 | 50 | 0 | 0 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 0 | 6 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| EXPEDITED ISS | 2 | 4 | 2 | 2 | 1 | 632 | 8 | 3 | 8 | 8 | 12 | 20 | 5 | 12 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 19 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| DIRECT | 145 | 143 | 111 | 198 | 91 | 309 | 249 | 567 | 474 | 226 | 280 | 0 | 87 | 0 | 0 | 89 | 96 | 152 | 129 | 111 | 92 | 157 | 120 | 88 | 327 | 124 | 283 | 53 | 173 | 155 | 363 | 184 | 217 | 85 | 136 | 132 | 78 | 147 | 108 | 93 | 44 | 110 | 121 | 76 | 113 | 80 |
| PERIODIC INI | 0 | 50 | 0 | 396 | 553 | 400 | 741 | 634 | 1494 | 4268 | 4264 | 3375 | 1550 | 121 | 0 | 0 | 0 | 40 | 30 | 0 | 0 | 0 | 573 | 182 | 71 | 385 | 295 | 1222 | 828 | 524 | 303 | 85 | 222 | 24 | 0 | 139 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PERIODIC FU | 80 | 56 | 0 | 96 | 64 | 0 | 0 | 3 | 10 | 9 | 9 | 1 | 122 | 44 | 0 | 0 | 0 | 6 | 3 | 0 | 0 | 0 | 10 | 0 | 0 | 0 | 3 | 2 | 13 | 20 | 24 | 0 | 0 | 0 | 0 | 10 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| PERIODIC ISS | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 54 | 17 | 50 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 28 | 110 | 0 | 0 | 4 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| TOTAL | 293 | 360 | 212 | 1,013 | 732 | 1,436 | 1,126 | 1,636 | 2,227 | 4,806 | 4,746 | 3,515 | 1,781 | 227 | 0 | 96 | 96 | 337 | 232 | 111 | 92 | 303 | 720 | 306 | 473 | 543 | 602 | 1,305 | 1,144 | 730 | 690 | 273 | 499 | 120 | 143 | 299 | 103 | 147 | 108 | 93 | 48 | 111 | 121 | 76 | 113 | 80 |
| PIPELINE + PENDING | 2,001 | 1,149 | 1,503 | 2,336 | 2,764 | 4,191 | 3,487 | 4,001 | 4,623 | 7,399 | 7,913 | 8,721 | 7,856 | 7,860 | 6,457 | 3,790 | 3,414 | 2,971 | 2,852 | 2,953 | 2,671 | 2,638 | 2,995 | 2,962 | 3,311 | 3,457 | 2,953 | 3,911 | 3,850 | 4,611 | 4,288 | 4,276 | 3,667 | 2,854 | 2,463 | 2,121 | 1,471 | 2,233 | 1,773 | 1,408 | 1,561 | 1,557 | 1,412 | 1,221 | 1,086 | 1,048 |
Eley, Christopher *:
Apotex cases are being held. John Quinn trying to get company to resubmit electronically.
PRODUCTS OF CONCERN
| PRODUCTS OF CONCERN | NOTIFYING DATE | OPEN/CLOSED | REPORTER/SOURCE | REQUESTED BY |
| Electronic Cigarettes | 7/24/09 | 7/6/11 | Consumers | Toni P-Hepp |
| Hyaluronidase/Lidocaine | 9/22/09 | Closed | Consumers | Joan Trankle |
| Tylenol Infant Drops | 1/1/10 | Closed | Consumers/ McNeil | Joan Trankle |
| Zicam | 1/4/10 | Closed | Mattrix/Consumers | Toni P-Hepp |
| Tysabri | 12/9/10 | Closed | Biogen | Dr. Dal Pan |
| Triad Alcohol Swabs | 1/28/11 | Closed | Triad - consumers | P. Diak/Min Chen |
| Evamist | 2/8/11 | Closed | Consumers | Adrienne Rothstein |
| TPN Contamination | 3/13/11 | Closed | Advanced Specialty Pharmacy | Thang La/Ann Corken |
| Human Chorionic Gonadatropin - HCG (weight Loss) | 5/9/11 | Closed | consumers | Joan Trankle |
| Simply Thick | 5/24/11 | Closed | Consumers | Joan Trankle |
| Compounding Pharmacies | Oct-12 | Closed | Multiple Sources | Emergency Team |
| Propofol | May-13 | Closed | JCB Labs/Fresenius | Dr. Marni Hall |
| Protamine Sulfate | Feb-13 | Closed | Fresenius | Jo Wyeth |
| Omontys - Peginesatide Acetate | 2/23/13 | Closed | Affymax | Jo Wyeth |
| Coumadin - Warfarin | Mar-13 | Closed | Taro | Scott Dallas |
| Avastin - Bevacizumab | 3/4/13 | Closed | Compounding Site | Dr. Marni Hall |
| Opana - Oxymorphone | 3/8/13 | Closed | CDC | Lauren Choi |
| Iclusig - Ponatinib | 3/8/13 | Closed | Ariad | Nancy Sager/Jo Wyeth |
| Magnesium Sulfate | 3/18/13 | Closed | MedPrep | Joan Trankle |
| Kenalog - Triamcinalone Acetonide | 3/19/13 | Closed | Alabama | Joann Lee |
| Fentanyl | 3/22/13 | Closed | Westward/Fresenius | Dr. Marni Hall |
| Midazolam | 3/22/13 | Closed | Westward/Fresenius | Dr. Marni Hall |
| Decadron - Dexamethasone | Apr-13 | Closed | MedPrep | Dr. Marni Hall |
| Methylprednisone | 5/23/13 | Closed | Main Street Pharmacy | Dr. Marni Hall |
| Calcium Gluconate | 8/8/13 | Closed | Specialty Compounding | Dr. Marni Hall |
FAERS-DMP Production
| Date | NEW CASE → DDE | Represent what New Case processed to Detailed Data Entry | |||||||||||
| Cases Completed | |||||||||||||
| Direct Paper | Expedited Paper | Periodic Paper | Total | ||||||||||
| February 2 - 6 | 757 | 848 | 603 | 2,208 | *4 NC Personnel at 12.5 cases per hour | ||||||||
| February 9 - 13 | 877 | 603 | 62 | 1,542 | |||||||||
| February 16 - 20 | 316 | 647 | 1 | 964 | *Holiday Monday & Snow Day Tuesday- Both days zero New Case | ||||||||
| February 23 - 27 | 893 | 775 | 1 | 1,669 | |||||||||
| March 2 - 6 | 650 | 731 | 0 | 1,381 | *Thursday & Friday Snow Days- Both days zero New Case | ||||||||
| March 9 - 13 | 1,148 | 798 | 217 | 2,163 | |||||||||
| March 16 - 22 | 1,230 | 566 | 953 | 2,749 | Overtime started 3/18 | ||||||||
| March 23 - 29 | 748 | 765 | 1923 | 3,436 | Overtime-FAERS Down on Weekend(fri-Sat) | ||||||||
| March 30 - April 5 | 851 | 558 | 1567 | 2,976 | Overtime-Network Issues on Monday(3/30) and Friday(4/3) | ||||||||
| April 6 - 12 | 797 | 538 | 957 | 2,292 | Overtime- New Case down 0n Friday(4/10) for 1 hour | ||||||||
| April 13 - 17 | 787 | 525 | 27 | 1,339 | Overtime-FAERS Down on Weekend(fri-Sat) | ||||||||
| April 20 - 26 | 941 | 582 | 350 | 1,873 | Overtime | ||||||||
| April 27 - May 1 | 849 | 401 | 94 | 1,344 | |||||||||
| May 4 - 8 | 670 | 666 | 216 | 1,552 | |||||||||
| May 11 - 15 | 825 | 628 | 191 | 1,644 | |||||||||
| May 18 - 22 | 831 | 469 | 97 | 1,397 | |||||||||
| May 25 - 29 | 619 | 378 | 5 | 1,002 | *Holiday week | ||||||||
| Jun 1 - 5 | 887 | 572 | 165 | 1,624 | |||||||||
| Jun 8 - 12 | 710 | 409 | 474 | 1,593 | |||||||||
| Jun 15 - 19 | 733 | 443 | 358 | 1,534 | |||||||||
| Jun 22 - 26 | 1006 | 516 | 72 | 1,594 | |||||||||
| Jun 29 - Jul 3 | 516 | 333 | 89 | 938 | *Holiday week and New Case down for 4 hours 7/1(Thurs) | ||||||||
| Jul 6 - 10 | 1012 | 435 | 216 | 1,663 | |||||||||
| Jul 13 - 17 | 739 | 325 | 459 | 1,523 | |||||||||
| Jul 20 - 24 | 1000 | 320 | 261 | 1,581 | |||||||||
| Jul 27 - 31 | 826 | 317 | 202 | 1,345 | |||||||||
| Aug 3 - 7 | 995 | 275 | 243 | 1,513 | |||||||||
| Aug 10 - 14 | 843 | 289 | 134 | 1,266 | |||||||||
| Aug 17 - 21 | 939 | 275 | 215 | 1,429 | |||||||||
| Aug 24 - 28 | 798 | 220 | 194 | 1,212 | |||||||||
| Aug 31 - Sep 4 | 822 | 191 | 43 | 1,056 | |||||||||
| Sep 7 - 11 | 654 | 102 | 172 | 928 | *Holiday week | *E2B MANDATION | |||||||
| Sep 14 - 18 | 746 | 115 | 32 | 893 | |||||||||
| Sep 21 - 25 | 843 | 68 | 22 | 933 | |||||||||
| Sep 28 - Oct 2 | 885 | 58 | 22 | 965 | |||||||||
| Oct 5 - Oct 9 | 775 | 98 | 12 | 885 | As of 2pm Friday- not full day | ||||||||
| Oct 12 -16 | 766 | 52 | 22 | 840 | *Holiday week | ||||||||
| Oct 19 -23 | 787 | 40 | 100 | 927 | |||||||||
| Oct 26 -30 | 782 | 40 | 16 | 838 | |||||||||
| Nov 2 - 6 | 785 | 36 | 4 | 825 | |||||||||
| Nov 9 - 13 | 713 | 23 | 4 | 740 | |||||||||
| Date | DETAILED DATA ENTRY → CODING | Represent what Detailed Data Entry processed to the Coders | |||||||||||
| Cases Completed | |||||||||||||
| Direct Paper | Expedited Paper | Periodic Paper | Total | ||||||||||
| February 2 - 6 | 669 | 556 | 58 | 1,283 | *7 DDE Personnel at 4 cases per hour | ||||||||
| February 9 - 13 | 586 | 661 | 160 | 1,407 | |||||||||
| February 16 - 20 | 816 | 532 | 21 | 1,369 | *Holiday week | ||||||||
| February 23 - 27 | 621 | 694 | 0 | 1,315 | |||||||||
| March 2 - 6 | 802 | 825 | 0 | 1,627 | |||||||||
| March 9 - 13 | 586 | 684 | 76 | 1,346 | |||||||||
| March 16 - 22 | 1,097 | 786 | 34 | 1,917 | Overtime started 3/18 | ||||||||
| March 23 - 29 | 1,243 | 803 | 111 | 2,157 | Overtime-FAERS Down on Weekend(fri-Sat) | ||||||||
| March 30 - April 5 | 1,093 | 591 | 1,176 | 2,860 | Overtime-Network Issues on Monday(3/30) and Friday(4/3) | ||||||||
| April 6 - 12 | 316 | 558 | 3,246 | 4,120 | Overtime | ||||||||
| April 13 - 17 | 859 | 430 | 2,045 | 3,334 | Overtime-FAERS Down on Weekend(fri-Sat) | ||||||||
| April 20 - 26 | 1,543 | 963 | 122 | 2,628 | Overtime | ||||||||
| April 27 - May 1 | 810 | 455 | 253 | 1,518 | Overtime-FAERS Down on Weekend(fri-Sat) | ||||||||
| May 4 - 8 | 716 | 701 | 49 | 1,466 | |||||||||
| May 11 - 15 | 766 | 670 | 38 | 1,474 | |||||||||
| May 18 - 22 | 784 | 524 | 166 | 1,474 | |||||||||
| May 25 - 29 | 707 | 376 | 82 | 1,165 | *Holiday week | ||||||||
| Jun 1 - 5 | 802 | 593 | 20 | 1,415 | |||||||||
| Jun 8 - 12 | 695 | 371 | 82 | 1,148 | |||||||||
| Jun 15 - 19 | 640 | 491 | 258 | 1,389 | |||||||||
| Jun 22 - 26 | 1,025 | 280 | 108 | 1,413 | |||||||||
| Jun 29 - Jul 3 | 693 | 378 | 307 | 1,378 | *Holiday week | ||||||||
| Jul 6 - 10 | 913 | 379 | 3 | 1,295 | |||||||||
| Jul 13 - 17 | 581 | 366 | 341 | 1,288 | |||||||||
| Jul 20 - 24 | 1,023 | 336 | 202 | 1,561 | |||||||||
| Jul 27 - 31 | 961 | 357 | 41 | 1,359 | |||||||||
| Aug 3 - 7 | 987 | 295 | 209 | 1,491 | |||||||||
| Aug 10 - 14 | 646 | 259 | 491 | 1,396 | |||||||||
| Aug 17 - 21 | 988 | 344 | 205 | 1,537 | |||||||||
| Aug 24 - 28 | 947 | 246 | 564 | 1,757 | |||||||||
| Aug 31 - Sep 4 | 969 | 256 | 101 | 1,326 | |||||||||
| Sep 7 - 11 | 637 | 101 | 199 | 937 | *Holiday week | *E2B MANDATION | |||||||
| Sep 14 - 18 | 867 | 150 | 40 | 1,057 | |||||||||
| Sep 21 - 25 | 859 | 76 | 25 | 960 | |||||||||
| Sep 28 - Oct 2 | 870 | 68 | 6 | 944 | |||||||||
| Oct 5 - Oct 9 | 806 | 86 | 32 | 924 | As of 2pm Friday- not full day | ||||||||
| Oct 12 -16 | 753 | 57 | 1 | 811 | *Holiday week | ||||||||
| Oct 19 -23 | 830 | 49 | 124 | 1,003 | |||||||||
| Oct 26 -30 | 776 | 42 | 12 | 830 | |||||||||
| Nov 2 - 6 | 806 | 34 | 7 | 847 | |||||||||
| Nov 9 - 13 | 695 | 32 | 5 | 732 | |||||||||
| Date | CODING → VALIDATION | Represent what the Coders processed to the Validators | |||||||||||
| Cases Completed | |||||||||||||
| Coding Direct Paper | Coding Expedited Paper | Coding Periodic Paper | Coding Expedited E2B | Coding Periodic E2B | Total | ||||||||
| February 2 - 6 | 384 | 705 | 52 | 409 | 0 | 1,550 | *4 Coders at 8 cases per hour | ||||||
| February 9 - 13 | 588 | 583 | 137 | 368 | 44 | 1,720 | |||||||
| February 16 - 20 | 93 | 591 | 59 | 390 | 0 | 1,133 | *Holiday week | ||||||
| February 23 - 27 | 371 | 443 | 1 | 344 | 2 | 1,161 | |||||||
| March 2 - 6 | 156 | 786 | 0 | 237 | 0 | 1,179 | |||||||
| March 9 - 13 | 546 | 718 | 4 | 359 | 4 | 1,631 | |||||||
| March 16 - 20 | 718 | 696 | 16 | 268 | 17 | 1,715 | |||||||
| March 23 - 29 | 77 | 840 | 98 | 318 | 53 | 1,386 | Overtime-FAERS Down on Weekend(fri-Sat) | ||||||
| March 30 - April 5 | 610 | 632 | 15 | 278 | 2 | 1,537 | Overtime-Network Issues on Monday(3/30) and Friday(4/3) | ||||||
| April 6 - 12 | 592 | 592 | 872 | 218 | 14 | 2,288 | Overtime | ||||||
| April 13 - 17 | 280 | 261 | 738 | 336 | 27 | 1,642 | Overtime-FAERS Down on Weekend(fri-Sat) | ||||||
| April 20 - 26 | 742 | 683 | 199 | 269 | 0 | 1,893 | Overtime | ||||||
| April 27 - May 1 | 1,206 | 720 | 13 | 412 | 0 | 2,351 | Overtime-FAERS Down on Weekend(fri-Sat) | ||||||
| May 4 - 8 | 973 | 719 | 11 | 312 | 10 | 2,025 | |||||||
| May 11 - 15 | 727 | 605 | 26 | 274 | 4 | 1,636 | |||||||
| May 18 - 22 | 542 | 515 | 221 | 323 | 0 | 1,601 | |||||||
| May 25 - 29 | 613 | 347 | 39 | 289 | 0 | 1,288 | *Holiday week | ||||||
| Jun 1 - 5 | 462 | 472 | 178 | 319 | 37 | 1,468 | |||||||
| Jun 8 - 12 | 442 | 580 | 10 | 351 | 0 | 1,383 | |||||||
| Jun 15 - 19 | 759 | 332 | 69 | 336 | 3 | 1,499 | |||||||
| Jun 22 - 26 | 787 | 462 | 214 | 369 | 17 | 1,849 | |||||||
| Jun 29 - Jul 3 | 610 | 307 | 50 | 377 | 3 | 1,347 | *Holiday week | ||||||
| Jul 6 - 10 | 645 | 428 | 7 | 544 | 0 | 1,624 | |||||||
| Jul 13 - 17 | 495 | 340 | 236 | 417 | 6 | 1,494 | |||||||
| Jul 20 - 24 | 977 | 392 | 42 | 322 | 1 | 1,734 | |||||||
| Jul 27 - 31 | 884 | 348 | 129 | 434 | 391 | 2,186 | |||||||
| Aug 3 - 7 | 677 | 262 | 277 | 399 | 60 | 1,675 | |||||||
| Aug 10 - 14 | 960 | 226 | 88 | 406 | 31 | 1,711 | |||||||
| Aug 17 - 21 | 779 | 321 | 28 | 367 | 17 | 1,512 | |||||||
| Aug 24 - 28 | 818 | 311 | 8 | 343 | 17 | 1,497 | |||||||
| Aug 31 - Sep 4 | 742 | 312 | 14 | 339 | 28 | 1,435 | |||||||
| Sep 7 - 11 | 573 | 121 | 15 | 382 | 14 | 1,105 | *Holiday week | *E2B MANDATION | |||||
| Sep 14 - 18 | 716 | 100 | 11 | 469 | 20 | 1,316 | |||||||
| Sep 21 - 25 | 854 | 89 | 25 | 350 | 199 | 1,517 | |||||||
| Sep 28 - Oct 2 | 846 | 59 | 4 | 399 | 200 | 1,508 | |||||||
| Oct 5 - Oct 9 | 792 | 56 | 130 | 451 | 76 | 1,505 | As of 2pm Friday- not full day | ||||||
| Oct 12 -16 | 821 | 78 | 0 | 387 | 199 | 1,485 | *Holiday week | ||||||
| Oct 19 -23 | 694 | 57 | 123 | 526 | 462 | 1,862 | |||||||
| Oct 26 -30 | 824 | 46 | 2 | 369 | 86 | 1,327 | |||||||
| Nov 2 - 6 | 850 | 39 | 20 | 477 | 124 | 1,510 | |||||||
| Nov 9 - 13 | 792 | 31 | 3 | 425 | 219 | 1,470 | |||||||
| 2 | |||||||||||||
| Date | VALIDATION → SAFETY EVALUATOR | Represent what the Validators processed to the Safety Evaluators | |||||||||||
| Cases Completed | |||||||||||||
| Coding Direct Paper | Coding Expedited Paper | Coding Periodic Paper | Coding Expedited E2B | Coding Periodic E2B | Validation Direct Paper | Validation Expedited Paper | Validation Periodic Paper | Validation Expedited E2B | Validation Periodic E2B | Total | |||
| February 2 - 6 | 204 | 9 | 0 | 0 | 37 | 558 | 608 | 82 | 382 | 0 | 1,880 | *6 Validators at 8 cases per hour | |
| February 9 - 13 | 0 | 0 | 0 | 0 | 0 | 502 | 724 | 188 | 572 | 113 | 2,099 | ||
| February 16 - 20 | 584 | 0 | 52 | 0 | 94 | 251 | 478 | 59 | 352 | 0 | 1,870 | *Holiday week | |
| February 23 - 27 | 338 | 174 | 0 | 9 | 195 | 368 | 539 | 1 | 307 | 2 | 1,933 | ||
| March 2 - 6 | 406 | 65 | 0 | 94 | 21 | 150 | 750 | 0 | 223 | 0 | 1,709 | ||
| March 9 - 13 | 183 | 11 | 72 | 74 | 39 | 515 | 648 | 4 | 320 | 4 | 1,870 | ||
| March 16 - 20 | 203 | 4 | 0 | 0 | 24 | 410 | 593 | 8 | 247 | 21 | 1,510 | DS Navigator down for 3 hours (18hours total) | |
| March 23 - 29 | 731 | 0 | 0 | 0 | 431 | 421 | 882 | 103 | 276 | 39 | 2,883 | Overtime-FAERS Down on Weekend(fri-Sat) | |
| March 30 - April 5 | 897 | 0 | 0 | 87 | 42 | 171 | 566 | 10 | 250 | 0 | 2,023 | Overtime-Network Issues on Monday(3/30) and Friday(4/3) | |
| April 6 - 12 | 104 | 1 | 1,337 | 50 | 242 | 976 | 609 | 75 | 194 | 16 | 3,604 | Overtime | |
| April 13 - 17 | 33 | 0 | 2,011 | 0 | 409 | 322 | 470 | 1,517 | 304 | 26 | 5,092 | Overtime-FAERS Down on Weekend(fri-Sat) | |
| April 20 - 24 | 385 | 0 | 736 | 72 | 109 | 408 | 389 | 205 | 261 | 0 | 2,565 | ||
| April 27 - May 1 | 81 | 1 | 7 | 7 | 0 | 1211 | 801 | 9 | 357 | 0 | 2,474 | ||
| May 4 - 8 | 0 | 0 | 1 | 0 | 153 | 859 | 731 | 8 | 261 | 9 | 2,022 | ||
| May 11 - 15 | 0 | 3 | 0 | 4 | 59 | 866 | 507 | 26 | 240 | 3 | 1,708 | ||
| May 18 - 22 | 1 | 2 | 0 | 0 | 14 | 731 | 703 | 224 | 201 | 0 | 1,876 | ||
| May 25 - 29 | 129 | 0 | 123 | 0 | 0 | 612 | 353 | 37 | 279 | 0 | 1,533 | *Holiday week | |
| Jun 1 - 5 | 216 | 0 | 270 | 3 | 178 | 414 | 586 | 145 | 276 | 18 | 2,106 | ||
| Jun 8 - 12 | 356 | 0 | 1 | 1 | 8 | 531 | 326 | 55 | 313 | 0 | 1,591 | ||
| Jun 15 - 19 | 48 | 50 | 0 | 144 | 0 | 702 | 582 | 72 | 283 | 1 | 1,882 | ||
| Jun 22 - 26 | 0 | 0 | 1 | 4 | 44 | 796 | 407 | 196 | 328 | 2 | 1,778 | ||
| Jun 29 - Jul 3 | 190 | 0 | 190 | 4 | 231 | 630 | 369 | 27 | 363 | 17 | 2,021 | *Holiday week | |
| Jul 6 - 10 | 273 | 1 | 179 | 11 | 57 | 588 | 373 | 51 | 396 | 0 | 1,929 | ||
| Jul 13 - 17 | 118 | 0 | 223 | 1 | 152 | 458 | 514 | 235 | 271 | 5 | 1,977 | ||
| Jul 20 - 24 | 77 | 0 | 92 | 0 | 39 | 780 | 340 | 43 | 345 | 1 | 1,717 | ||
| Jul 27 - 31 | 0 | 0 | 97 | 6 | 0 | 934 | 294 | 46 | 374 | 20 | 1,771 | ||
| Aug 3 - 7 | 189 | 17 | 13 | 3 | 344 | 827 | 309 | 320 | 328 | 51 | 2,401 | ||
| Aug 10 - 14 | 5 | 4 | 256 | 5 | 395 | 1059 | 257 | 128 | 324 | 26 | 2,459 | ||
| Aug 17 - 21 | 5 | 0 | 540 | 3 | 343 | 796 | 326 | 28 | 382 | 12 | 2,435 | ||
| Aug 24 - 28 | 80 | 2 | 398 | 1 | 439 | 772 | 221 | 7 | 299 | 98 | 2,317 | ||
| Aug 31 - Sep 4 | 379 | 0 | 110 | 3 | 326 | 743 | 304 | 4 | 292 | 16 | 2,177 | ||
| Sep 7 - 11 | 0 | 1 | 392 | 62 | 377 | 653 | 125 | 24 | 314 | 5 | 1,953 | *Holiday week | *E2B MANDATION |
| Sep 14 - 18 | 0 | 7 | 62 | 69 | 247 | 657 | 96 | 10 | 242 | 19 | 1,409 | *QA SRP Cases | |
| Sep 21 - 25 | 0 | 0 | 22 | 123 | 590 | 788 | 105 | 25 | 421 | 133 | 2,207 | ||
| Sep 28 - Oct 2 | 0 | 6 | 2 | 158 | 431 | 811 | 56 | 4 | 348 | 195 | 2,011 | ||
| Oct 5 - Oct 9 | 0 | 0 | 5 | 26 | 124 | 829 | 58 | 3 | 294 | 3 | 1,342 | *QA MED ERROR | As of 2pm Friday- not full day |
| Oct 12 -16 | 0 | 0 | 0 | 104 | 195 | 771 | 78 | 129 | 356 | 125 | 1,758 | *Holiday week | |
| Oct 19 -23 | 0 | 0 | 2 | 0 | 23 | 791 | 59 | 87 | 459 | 390 | 1,811 | ||
| Oct 26 -30 | 0 | 3 | 2 | 125 | 19 | 786 | 32 | 2 | 325 | 294 | 1,588 | ||
| Nov 2 - 6 | 1 | 0 | 0 | 154 | 187 | 883 | 38 | 51 | 419 | 134 | 1,867 | ||
| Nov 9 - 13 | 2 | 0 | 0 | 72 | 29 | 690 | 33 | 0 | 373 | 169 | 1,368 |
CASES Received
| Date | Cases Received | |||||||||
| DCC Weekly | *Our goal is to see a decrease in Expedited Paper and an Increase in E2B cases | |||||||||
| Direct Paper | Expedited Paper | Periodic Paper | Expedited E2B (stopped) | Periodic E2B (stopped) | Total | |||||
| February 2 - 6 | 723 | 696 | 556 | 411 | 56 | 2,442 | ||||
| February 9 - 13 | 976 | 690 | 341 | 546 | 57 | 2,610 | ||||
| February 16 - 20 | 740 | 1,122 | 109 | 373 | 163 | 2,507 | ||||
| February 23 - 27 | 847 | 629 | 167 | 338 | 120 | 2,101 | ||||
| March 2 - 6 | 903 | 783 | 2774 | 1814 | 408 | 6,682 | ||||
| March 9 - 13 | 1046 | 761 | 124 | 369 | 38 | 2,338 | ||||
| March 16 - 20 | 833 | 570 | 99 | 295 | 473 | 2,270 | ||||
| March 23 - 27 | 801 | 648 | 80 | 323 | 52 | 1,904 | ||||
| March 30 - April 3 | 750 | 577 | 514 | 327 | 197 | 2,365 | ||||
| April 6 - 10 | 780 | 510 | 632 | 310 | 410 | 2,642 | ||||
| April 13 - 17 | 923 | 595 | 75 | 379 | 153 | 2,125 | ||||
| April 20 - 24 | 982 | 539 | 440 | 327 | 49 | 2,337 | ||||
| April 27 - May 1 | 812 | 606 | 51 | 399 | 76 | 1,944 | ||||
| May 4 - 8 | 674 | 689 | 369 | 347 | 60 | 2,139 | ||||
| May 11 - 15 | 803 | 582 | 65 | 263 | 35 | 1,748 | ||||
| May 18 - 22 | 796 | 511 | 173 | 345 | 69 | 1,894 | ||||
| May 25 - 29 | 723 | 494 | 53 | 278 | 69 | 1,617 | ||||
| Jun 1 - 5 | 846 | 476 | 1,294 | 322 | 49 | 2,987 | ||||
| Jun 8 - 12 | 711 | 426 | 259 | 356 | 114 | 1,866 | ||||
| Jun 15 - 19 | 868 | 446 | 56 | 615 | 106 | 2,091 | ||||
| Jun 22 - 26 | 874 | 376 | 134 | 441 | 153 | 1,978 | ||||
| Jun 29 - Jul 3 | 660 | 331 | 921 | 335 | 146 | 2,393 | ||||
| Jul 6 - 10 | 809 | 449 | 20 | 496 | 147 | 1,921 | ||||
| Jul 13 - 17 | 762 | 342 | 149 | 392 | 144 | 1,789 | ||||
| Jul 20 - 24 | 963 | 323 | 32 | 384 | 1013 | 2,715 | ||||
| Jul 27 - 31 | 1050 | 316 | 57 | 418 | 216 | 2,057 | ||||
| Aug 3 - 7 | 803 | 253 | 73 | 366 | 896 | 2,391 | ||||
| Aug 10 - 14 | 840 | 335 | 108 | 434 | 209 | 1,926 | ||||
| Aug 17 - 21 | 838 | 234 | 90 | 329 | 255 | 1,746 | ||||
| Aug 24 - 28 | 843 | 226 | 1,373 | 427 | 227 | 3,096 | ||||
| Aug 31 - Sep 4 | 800 | 167 | 286 | 377 | 183 | 1,813 | ||||
| Sep 7 - 11 | 639 | 94 | 93 | 476 | 256 | 1,558 | *E2B MANDATION | Gateway Issues & Bruce loading issues | ||
| Sep 14 - 18 | 783 | 104 | 38 | 561 | 1091 | 2,577 | ||||
| Sep 21 - 25 | 817 | 60 | 9 | 533 | 200 | 1,619 | Gateway Issues & Bruce loading issues | (Bruce given his own thread for loading xml/pdfs) | ||
| Sep 28 - Oct 2 | 837 | 59 | 24 | 508 | 176 | 1,604 | ||||
| Oct 5 - Oct 9 | 814 | 86 | 11 | 416 | 304 | 1,631 | Bruce Laptop Issues-delayed loading | |||
| Oct 12 - Oct 16 | 786 | 57 | 22 | 472 | 546 | 1,883 | Holiday | |||
| Oct 19 - Oct 23 | 821 | 39 | 130 | 538 | 195 | 1,723 | ||||
| Oct 26 - Oct 30 | 734 | 34 | 7 | 587 | 208 | 1,570 | ||||
| Nov 2 - 6 | 759 | 34 | 6 | 733 | 245 | 1,777 | ||||
| og | 687 | 23 | 2 | 489 | 210 | 1,411 | ||||
| 2 |
Eley, Christopher *:
Add 632 for the Apotex cases being held at the request by the FDA. The company will resubmit electronically.
Eley, Christopher *:
At the request of the FDA, 116 of these cases(Hyperion) will be expedited because they are under review.
Eley, Christopher *:
Received:
2/18 = 359 2/19 = 386 2/20 = 377 Eley, Christopher *:
Takeda Resubmissions Eley, Christopher *:
1,207 are Lioresal paper submissions. The FDA has instructed to hold. The manufacturer will resubmit electronically.
SRP
File details come from the government source that posted it. Updated .