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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