CDER 2007 Update - Accessible Text For Charts

Drug Review

Generic Drug Review

Over the Counter Drug Review

Pediatric Development and Maternal Health

Drug Promotion Review

Drug Safety Surveillance

Drug Recalls and Safety Based Withdrawals

Compliance Oversight

International Activities

CDER 2007 Update
Accessible Data for Images

Priority NDA and BLA Approvals--Median times and approvals by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 20 approvals with a median FDA review time of 6.2 months and a median total approval time of 6.4 months.
In 1998, there were 25 approvals with a median FDA review time of 6.2 months and a median total approval time of 6.4 months.
In 1999, there were 28 approvals with a median FDA review time of 6.1 months and a median total approval time of 6.1 months.
In 2000, there were 20 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2001, there were 10 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2002, there were 11 approvals with a median FDA review time of 13.8 months and a median total approval time of 19.1 months.
In 2003, there were 14 approvals with a median FDA review time of 7.7 months and a median total approval time of 7.7 months.
In 2004, there were 29 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2005, there were 22 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2006, there were 21 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2007, there were 23 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.

Priority NDA and BLAs--Filings, actions and approval percentages by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 32 filings, 35 actions and a 57 percent approval percentage.
In 1998, there were 27 filings, 46 actions and a 54 percent approval percentage.
In 1999, there were 31 filings, 43 actions and a 65 percent approval percentage.
In 2000, there were 21 filings, 41 actions and a 49 percent approval percentage.
In 2001, there were 7 filings, 27 actions and a 37 percent approval percentage.
In 2002, there were 19 filings, 18 actions and a 61 percent approval percentage.
In 2003, there were 18 filings, 26 actions and a 54 percent approval percentage.
In 2004, there were 31 filings, 42 actions and a 69 percent approval percentage.
In 2005, there were 29 filings, 36 actions and a 61 percent approval percentage.
In 2006, there were 26 filings, 38 actions and a 55 percent approval percentage.
In 2007, there were 24 filings, 35 actions and a 66 percent approval percentage.

Priority NME and new BLA Approvals--Median times and approvals by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 9 approvals with a median FDA review time of 6.4 months and a median total approval time of 6.7 months.
In 1998, there were 16 approvals with a median FDA review time of 6.2 months and a median total approval time of 6.2 months.
In 1999, there were 19 approvals with a median FDA review time of 6.3 months and a median total approval time of 6.3 months.
In 2000, there were 9 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2001, there were 7 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2002, there were 7 approvals with a median FDA review time of 13.8 months and a median total approval time of 16.3 months.
In 2003, there were 9 approvals with a median FDA review time of 7.7 months and a median total approval time of 6.7 months.
In 2004, there were 21 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2005, there were 15 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2006, there were 10 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2007, there were 8 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.

Priority NME and new BLAs--Filings by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 16 filings.
In 1998, there were 15 filings.
In 1999, there were 14 filings.
In 2000, there were 14 filings.
In 2001, there were 5 filings.
In 2002, there were 10 filings.
In 2003, there were 16 filings.
In 2004, there were 17 filings.
In 2005, there were 17 filings.
In 2006, there were 7 filings.
In 2007, there were 10 filings.

Standard NDA and BLA Approvals--Median times and approvals by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 101 approvals with a median FDA review time of 14.7 months and a median total approval time of 18.7 months.
In 1998, there were 65 approvals with a median FDA review time of 12.0 months and a median total approval time of 12.0 months.
In 1999, there were 55 approvals with a median FDA review time of 12.0 months and a median total approval time of 13.8 months.
In 2000, there were 78 approvals with a median FDA review time of 12.0 months and a median total approval time of 12.0 months.
In 2001, there were 56 approvals with a median FDA review time of 12.0 months and a median total approval time of 14.0 months.
In 2002, there were 67 approvals with a median FDA review time of 12.7 months and a median total approval time of 15.3 months.
In 2003, there were 58 approvals with a median FDA review time of 11.9 months and a median total approval time of 15.4 months.
In 2004, there were 90 approvals with a median FDA review time of 11.9 months and a median total approval time of 12.9 months.
In 2005, there were 58 approvals with a median FDA review time of 11.8 months and a median total approval time of 13.1 months.
In 2006, there were 80 approvals with a median FDA review time of 12.0 months and a median total approval time of 13.0 months.
In 2007, there were 55 approvals with a median FDA review time of 10.2 months and a median total approval time of 10.4 months.

Standard NDA and BLAs--Filings, actions and approval percentages by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 92 filings, 200 actions and a 51 percent approval percentage.
In 1998, there were 87 filings, 153 actions and a 42 percent approval percentage.
In 1999, there were 101 filings, 147 actions and a 37 percent approval percentage.
In 2000, there were 87 filings, 197 actions and a 40 percent approval percentage.
In 2001, there were 88 filings, 143 actions and a 39 percent approval percentage.
In 2002, there were 79 filings, 154 actions and a 44 percent approval percentage.
In 2003, there were 89 filings, 139 actions and a 42 percent approval percentage.
In 2004, there were 75 filings, 162 actions and a 56 percent approval percentage.
In 2005, there were 82 filings, 107 actions and a 54 percent approval percentage.
In 2006, there were 90 filings, 158 actions and a 51 percent approval percentage.
In 2007, there were 86 filings, 125 actions and a 44 percent approval percentage.

Standard NME and new BLA Approvals--Median times and approvals by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 30 approvals with a median FDA review time of 14.4 months and a median total approval time of 15.0 months.
In 1998, there were 14 approvals with a median FDA review time of 12.3months and a median total approval time of 13.4 months.
In 1999, there were 16 approvals with a median FDA review time of 14.0 months and a median total approval time of 16.3 months.
In 2000, there were 18 approvals with a median FDA review time of 15.4 months and a median total approval time of 19.9 months.
In 2001, there were 17 approvals with a median FDA review time of 15.7 months and a median total approval time of 19.0 months.
In 2002, there were 10 approvals with a median FDA review time of 12.5 months and a median total approval time of 15.9 months.
In 2003, there were 12 approvals with a median FDA review time of 13.8 months and a median total approval time of 23.1 months.
In 2004, there were 15 approvals with a median FDA review time of 16.0 months and a median total approval time of 24.7 months.
In 2005, there were 5 approvals with a median FDA review time of 15.6 months and a median total approval time of 23.0 months.
In 2006, there were 12 approvals with a median FDA review time of 12.5 months and a median total approval time of 13.7 months.
In 2007, there were 10 approvals with a median FDA review time of 12.9 months and a median total approval time of 12.9 months.

Standard NMEs and new BLAs--Filings by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 25 filings.
In 1998, there were 28 filings.
In 1999, there were 22 filings.
In 2000, there were 12 filings.
In 2001, there were 25 filings.
In 2002, there were 13 filings.
In 2003, there were 12 filings.
In 2004, there were 16 filings.
In 2005, there were 19 filings.
In 2006, there were 17 filings.
In 2007, there were 26 filings.

Priority New or Expanded Use Approvals--Median times and approvals by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 4 approvals with a median FDA review time of 4.4 months and a median total approval time of 4.4 months.
In 1998, there were 13 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 1999, there were 9 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2000, there were 18 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2001, there were 6 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2002, there were 19 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2003, there were 21 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2004, there were 48 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2005, there were 36 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2006, there were 39 approvals with a median FDA review time of 6.0 months and a median total approval time of 6.0 months.
In 2007, there were 36 approvals with a median FDA review time of 6.0 months and a median total approval time of 7.5 months.

Priority New or Expanded Uses--Actions and approval percentages by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 7 actions and a 57 percent approval percentage.
In 1998, there were 13 actions and a 100 percent approval percentage.
In 1999, there were 19 actions and a 47 percent approval percentage.
In 2000, there were 23 actions and a 78 percent approval percentage.
In 2001, there were 10 actions and a 60 percent approval percentage.
In 2002, there were 36 actions and a 53 percent approval percentage.
In 2003, there were 33 actions and a 64 percent approval percentage.
In 2004, there were 64 actions and a 75 percent approval percentage.
In 2005, there were 52 actions and a 69 percent approval percentage.
In 2006, there were 52 actions and a 75 percent approval percentage.
In 2005, there were 42 actions and a 86 percent approval percentage.

Standard New or Expanded Use Approvals--Median times and approvals by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 104 approvals with a median FDA review time of 11.9 months and a median total approval time of 12.0 months.
In 1998, there were 111 approvals with a median FDA review time of 11.9 months and a median total approval time of 12.0 months.
In 1999, there were 88 approvals with a median FDA review time of 11.0 months and a median total approval time of 11.3 months.
In 2000, there were 116 approvals with a median FDA review time of 10.0 months and a median total approval time of 10.0 months.
In 2001, there were 85 approvals with a median FDA review time of 10.7 months and a median total approval time of 11.3 months.
In 2002, there were 133 approvals with a median FDA review time of 10.0 months and a median total approval time of 10.0 months.
In 2003, there were 110 approvals with a median FDA review time of 10.0 months and a median total approval time of 10.0 months.
In 2004, there were 99 approvals with a median FDA review time of 10.0 months and a median total approval time of 10.0 months.
In 2005, there were 105 approvals with a median FDA review time of 10.0 months and a median total approval time of 10.0 months.
In 2006, there were 98 approvals with a median FDA review time of 9.9 months and a median total approval time of 9.9 months.
In 2007, there were 91 approvals with a median FDA review time of 10.0 months and a median total approval time of 11.8 months.

Standard New or Expanded Uses--Actions and approval percentages by calendar year, including therapeutic biologics starting in 2004:

In 1997, there were 182 actions and a 57 percent approval percentage.
In 1998, there were 160 actions and a 69 percent approval percentage.
In 1999, there were 165 actions and a 53 percent approval percentage.
In 2000, there were 182 actions and a 64 percent approval percentage.
In 2001, there were 203 actions and a 42 percent approval percentage.
In 2002, there were 237 actions and a 56 percent approval percentage.
In 2003, there were 178 actions and a 62 percent approval percentage.
In 2004, there were 161 actions and a 61 percent approval percentage.
In 2005, there were 171 actions and a 61 percent approval percentage.
In 2006, there were 133 actions and a 74 percent approval percentage.
In 2007, there were 109 actions and a 83 percent approval percentage.

Generic Drug Approvals--Number of approvals and median approval times by calendar year data:

In 1997, there were 273 approvals in a median time of 19.3 months.
In 1998, there were 225 approvals in a median time of 18.0 months.
In 1999, there were 186 approvals in a median time of 18.6 months.
In 2000, there were 244 approvals in a median time of 18.2 months.
In 2001, there were 234 approvals in a median time of 18.1 months.
In 2002, there were 321 approvals in a median time of 18.3 months.
In 2003, there were 263 approvals in a median time of 17.0 months.
In 2004, there were 380 approvals in a median time of 15.7 months.
In 2005, there were 344 approvals in a median time of 16.4 months.
In 2006, there were 371 approvals in a median time of 17.5 months.
In 2007, there were 495 approvals in a median time of 19.3 months.

Generic Drug Tentative Approvals--Calendar year data:

In 1997, there were 40 tentative approvals.
In 1998, there were 40 tentative approvals.
In 1999, there were 56 tentative approvals.
In 2000, there were 61 tentative approvals.
In 2001, there were 73 tentative approvals.
In 2002, there were 63 tentative approvals.
In 2003, there were 101 tentative approvals.
In 2004, there were 95 tentative approvals.
In 2005, there were 108 tentative approvals.
In 2006, there were 164 tentative approvals.
In 2007, there were 188 tentative approvals.

Generic Drug Applications Received (workload in future years)--Calendar year data:

In 1997, there were 330 applications received.
In 1998, there were 345 applications received.
In 1999, there were 296 applications received.
In 2000, there were 365 applications received.
In 2001, there were 320 applications received.
In 2002, there were 392 applications received.
In 2003, there were 479 applications received.
In 2004, there were 635 applications received.
In 2005, there were 777 applications received.
In 2006, there were 828 applications received.
In 2007, there were 882 applications received.

In 1997, there were 9 new approvals or Rx-to-OTC switches and 1 new use.
In 1998, there were 8 new approvals or Rx-to-OTC switches and 1 new uses.
In 1999, there were 5 new approvals or Rx-to-OTC switches and 7 new uses.
In 2000, there were 8 new approvals or Rx-to-OTC switches and 3 new uses.
In 2001, there were 6 new approvals or Rx-to-OTC switches and 3 new uses.
In 2002, there were 13 new approvals or Rx-to-OTC switches and 1 new use.
In 2003, there was 1 new approval or Rx-to-OTC switch.
In 2004, there were 5 new approvals or Rx-to-OTC switches and 2 new uses.
In 2005, there were 5 new approvals or Rx-to-OTC switches and 3 new uses.
In 2006, there were 13 new approvals or Rx-to-OTC switches.
In 2007, there were 8 new approvals or Rx-to-OTC switches and 1 new use.

In 1999, there were 98 written requests issued, 3 pediatric exclusivity labeling changes granted and 12 pediatric exclusivity determinations made.
In 2000, there were 45 written requests issued, 11 pediatric exclusivity labeling changes granted and 17 pediatric exclusivity determinations made.
In 2001, there were 69 written requests issued, 12 pediatric exclusivity labeling changes granted and 23 pediatric exclusivity determinations made.
In 2002, there were 21 written requests issued, 19 pediatric exclusivity labeling changes granted and 20 pediatric exclusivity determinations made.
In 2003, there were 24 written requests issued, 15 pediatric exclusivity labeling changes granted and 23 pediatric exclusivity determinations made.
In 2004, there were 19 written requests issued, 25 pediatric exclusivity labeling changes granted and 17 pediatric exclusivity determinations made.
In 2005, there were 10 written requests issued, 25 pediatric exclusivity labeling changes granted and 15 pediatric exclusivity determinations made.
In 2006, there were 22 written requests issued, 14 pediatric exclusivity labeling changes granted and 18 pediatric exclusivity determinations made.
In 2007, there were 20 written requests issued, 17 pediatric exclusivity labeling changes granted and 14 pediatric exclusivity determinations made.

In 1997, there were 154 initial letters citing violations and 91 follow-up letters citing violations.
In 1998, there were 158 initial letters citing violations and 79 follow-up letters citing violations.
In 1999, there were 115 initial letters citing violations and 56 follow-up letters citing violations.
In 2000, there were 80 initial letters citing violations and 37 follow-up letters citing violations.
In 2001, there were 71 initial letters citing violations and 34 follow-up letters citing violations.
In 2002, there were 29 initial letters citing violations and 9 follow-up letters citing violations.
In 2003, there were 25 initial letters citing violations and 17 follow-up letters citing violations.
In 2004, there were 23 initial letters citing violations and 33 follow-up letters citing violations.
In 2005, there were 29 initial letters citing violations and 31 follow-up letters citing violations.
In 2006, there were 22 initial letters citing violations and 48 follow-up letters citing violations.
In 2007, there were 20 initial letters citing violations and 39 follow-up letters citing violations.

In 1997, there were 539 launch campaign advisory letters.
In 1998, there were 399 launch campaign advisory letters.
In 1999, there were 350 launch campaign advisory letters and 773 other advisory letters.
In 2000, there were 276 launch campaign advisory letters and 515 other advisory letters.
In 2001, there were 178 launch campaign advisory letters and 597 other advisory letters.
In 2002, there were 186 launch campaign advisory letters and 465 other advisory letters.
In 2003, there were 185 launch campaign advisory letters and 510 other advisory letters.
In 2004, there were 184 launch campaign advisory letters and 571 other advisory letters.
In 2005, there were 158 launch campaign advisory letters and 470 other advisory letters.
In 2006, there were 197 launch campaign advisory letters and 466 other advisory letters.
In 2007, there were 129 launch campaign advisory letters and 526 other advisory letters.

2007: 188 (26%)
2006: 150 (20%)
2005: 203 (30%)
2004: 217 (27%)
2003: 254 (34%)
2002: 188 (27%)
2001: 190 (22%)
2000: 215 (24%)
1999: 247 (19%)
1998: 282 (44%)
1997: 240 (31%)

In 1997, there were 212,978 reports of suspected drug-related adverse events that included 16,217 MedWatch reports directly from individuals; 37,849 manufacturer 15-day (expedited) reports; 144,479 manufacturer periodic reports; and 14,443 follow-up adjustments.
In 1998, there were 247,607 reports of suspected drug-related adverse events that included 15,279 MedWatch reports directly from individuals; 71,584 manufacturer 15-day (expedited) reports; 74,508 serious manufacturer periodic reports; and 86,236 nonserious manufacturer periodic reports.
In 1999, there were 278,266 reports of suspected drug-related adverse events that included 16,205 MedWatch reports directly from individuals; 81,625 manufacturer 15-day (expedited) reports; 127,468 serious manufacturer periodic reports; and 59,968 nonserious manufacturer periodic reports.
In 2000, there were 266,978 reports of suspected drug-related adverse events that included 16,137 MedWatch reports directly from individuals; 95,030 manufacturer 15-day (expedited) reports; 89,297 serious manufacturer periodic reports; and 66,514 nonserious manufacturer periodic reports.
In 2001, there were 285,107 reports of suspected drug-related adverse events that included 19,311 MedWatch reports directly from individuals; 115,014 manufacturer 15-day (expedited) reports; 70,305 serious manufacturer periodic reports; and 80,477 nonserious manufacturer periodic reports.
In 2002, there were 322,691 reports of suspected drug-related adverse events that included 20,442 MedWatch reports directly from individuals; 128,874 manufacturer 15-day (expedited) reports; 36,924 serious manufacturer periodic reports; and 136,451 nonserious manufacturer periodic reports.
In 2003, there were 370,898 reports of suspected drug-related adverse events that included 22,951 MedWatch reports directly from individuals; 144,316 manufacturer 15-day (expedited) reports; 59,007 serious manufacturer periodic reports; and 144,624 nonserious manufacturer periodic reports.
In 2004, there were 423,031 reports of suspected drug-related adverse events that included 21,661 MedWatch reports directly from individuals; 162,097 manufacturer 15-day (expedited) reports; 89,944 serious manufacturer periodic reports; and 149,329 nonserious manufacturer periodic reports.
In 2005, there were 464,068 reports of suspected drug-related adverse events: 25,325 MedWatch reports directly from individuals. 213,537 manufacturer 15-day (expedited) reports. 84,770 serious manufacturer periodic reports. 140,436 nonserious manufacturer periodic reports.
In 2006, there were 471,679 reports of suspected drug-related adverse events: 20,979 MedWatch reports directly from individuals. 220,245 manufacturer 15-day (expedited) reports. 230,455 serious and expected or nonserious manufacturer periodic reports.
In 2007, there were 482,155 reports of suspected drug-related adverse events: 23,033 MedWatch reports directly from individuals. 230,922 manufacturer 15-day reports for adverse events that are both serious and unexpected (not in the approved labeling). 228,200 manufacturer periodic reports for adverse events that are both serious and expected or non-serious.

Drug Recalls--Fiscal year data:

In 1997, there were 248 recalls of prescription drugs and 34 recalls of over-the-counter drugs.
In 1998, there were 176 recalls of prescription drugs and 88 recalls of over-the-counter drugs.
In 1999, there were 352 recalls of prescription drugs and 72 recalls of over-the-counter drugs.
In 2000, there were 316 recalls of prescription drugs and 156 recalls of over-the-counter drugs.
In 2001, there were 248 recalls of prescription drugs and 72 recalls of over-the-counter drugs.
In 2002, there were 354 recalls of prescription drugs and 83 recalls of over-the-counter drugs.
In 2003, there were 254 recalls of prescription drugs and 88 recalls of over-the-counter drugs.
In 2004, there were 215 recalls of prescription drugs and 71 recalls of over-the-counter drugs.
In 2005, there were 401 recalls of prescription drugs and 101 recalls of over-the-counter drugs.
In 2006, there were 240 recalls of prescription drugs and 121 recalls of over-the-counter drugs.
In 2007, there were 851 recalls of prescription drugs and 136 recalls of over-the-counter drugs.

Safety-Based Withdrawals--NMEs approved Jan. 1, 1971, to May 31, 2007, and BLAs approved Oct. 1, 2003, to May 31, 2007.

For the pre-PDUFA receipt period there were 16 withdrawals (3.3 percent) of 488 medicines.
For the PDUFA receipt period there were 13 withdrawals (3.6 percent) of 363 medicines.

In 1999, there were 2,020 MedWatch drug quality reports and 296 field alerts.
In 2000, there were 2,125 MedWatch drug quality reports and 281 field alerts.
In 2001, there were 2,469 MedWatch drug quality reports and 299 field alerts.
In 2002, there were 2,800 MedWatch drug quality reports and 413 field alerts.
In 2003, there were 2,864 MedWatch drug quality reports and 447 field alerts.
In 2004, there were 3,064 MedWatch drug quality reports and 374 field alerts.
In 2005, there were 2,864 MedWatch drug quality reports and 325 field alerts.
In 2006, there were 2,332 MedWatch drug quality reports and 311 field alerts.
In 2007, there were 3,311 MedWatch drug quality reports and 318 field alerts.

In 2007, the types of product defects and their percentages of the total were formulation/potency, 42 percent; mixup, 2 percent ; adverse drug reports, 12 percent; contamination, 10 percent; labeling, 5 percent; tampering, 1 percent; packaging, 27 percent; and other, 1 percent.

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Export Certificates Issued--Fiscal year data:

In 1997, there were 4,378 export certificates issued.
In 1998, there were 4,382 export certificates issued.
In 1999, there were 3,973 export certificates issued.
In 2000, there were 4,197 export certificates issued.
In 2001, there were 4,544 export certificates issued.
In 2002, there were 4,762 export certificates issued.
In 2003, there were 5,509 export certificates issued.
In 2004, there were 4,491 export certificates issued.
In 2005, there were 5,207 export certificates issued.
In 2006, there were 6,420 export certificates issued.
In 2007, there were 7,724 export certificates issued.

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Date created: July 31, 2008