Time savings, in months, under planned changes in FDA drugapproval process. Source: Council on Competitiveness.
Preclinical Testing
Current Duration: 18
Accelerated Approval DrugsNew Time: 15Months Saved: 3
All Other Drugs (Non-accelerated)New Time: 15Months Saved: 3
Major Reasons for Savings: International harmonization,computerized data
IND Approval
Current Duration: 1
Accelerated Approval DrugsNew Time: 1Months Saved: 0
All Other Drugs (Non-accelerated)New Time: 1Months Saved: 0
IND Phase I
Current Duration: 6
Accelerated Approval DrugsNew Time: 6Months Saved: 0
All Other Drugs (Non-accelerated)New Time: 6Months Saved: 0
IND Phase II/III
Current Duration: 18 (Phase II); 36 (Phase III)
Accelerated Approval DrugsNew Time: 34 (total)Months Saved: 20 (total)
All Other Drugs (Non-accelerated)New Time: 18 (Phase II); 28 (Phase III)Months Saved: 0 (Phase II); 8 (Phase III)
Major Reasons for Savings: Fewer clinical trials (accelerated);computerized data (Phase III)
NDA Preparation
Current Duration: 8
Accelerated Approval DrugsNew Time: 4Months Saved: 4
All Other Drugs (Non-accelerated)New Time: 4Months Saved: 4
Major Reasons for Savings: Computerized data; less datagenerated
FDA Approval
Current Duration: 30
Accelerated Approval DrugsNew Time: 6Months Saved: 24
All Other Drugs (Non-accelerated)New Time: 12Months Saved: 18
Major Reasons for Savings: Computerization, external reviewexpedited (accelerated)
Total Time (months)
Current Duration: 117
Accelerated Approval DrugsNew Time: 66Months Saved: 51
All Other Drugs (Non-accelerated)New Time: 84Months Saved: 33
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