Table 1. Duration Between Investigational New Drug Application and New Drug Application (NDA) or Biologics License Application (BLA) Submission Date for Novel Therapeutics Approved by the Food and Drug Administration From 2015 to 2022 .
| Total No. (%) | Approvals using no expedited programs | Approvals using ≥1 expedited programs | P value | |||
|---|---|---|---|---|---|---|
| No. (%) | Median (IQR), y | No. (%) | Median (IQR), y | |||
| Overall | 340 (100) | 144 (42.4) | 7.2 (5.3-9.5) | 196 (67.6) | 6.0 (4.0-8.2) | .001 |
| Therapeutic type | ||||||
| BLA | 96 (28.2) | 33 (34.4) | 7.5 (5.7-10.1) | 63 (65.6) | 6.5 (4.0-8.3) | .02 |
| NDA | 244 (71.8) | 111 (45.5) | 7.0 (5.2-9.0) | 133 (54.5) | 5.9 (4.1-8.2) | .008 |
| Therapeutic area | ||||||
| Cancer and hematology | 120 (35.3) | 28 (23.3) | 6.9 (5.7-11.4) | 92 (76.7) | 5.7 (4.0-7.9) | .007 |
| Infectious disease | 44 (12.9) | 9 (20.5) | 7.7 (2.3-9.1) | 35 (79.5) | 8.0 (3.6-10.4) | .49 |
| CVD, diabetes, and hyperlipidemia | 22 (6.5) | 14 (63.6) | 5.4 (4.4-8.1) | 8 (26.3) | 7.5 (6.7-10.9) | .19 |
| Autoimmune, musculoskeletal, and dermatology | 41 (12.1) | 25 (61.0) | 6.5 (5.5-7.7) | 16 (39.0) | 5.9 (4.6-7.2) | .14 |
| Neurology and psychiatry | 46 (13.5) | 30 (65.2) | 7.5 (6.0-8.7) | 16 (34.8) | 5.2 (4.4-7.5) | .07 |
| Othera | 67 (19.7) | 38 (56.7) | 7.3 (5.0-10.7) | 29 (43.3) | 6.0 (4.0-7.5) | .03 |
Abbreviation: CVD, cardiovascular disease.
a
Other included endocrinology (excluding diabetes) and metabolic disorders; gastroenterology; gynecology; nephrology; opthalmology; pulmonology; and therapeutics for the treatment of amyloidosis, prevention of nausea and vomiting (after surgery or delayed phase chemotherapy–induced), induction and maintenance of procedural sedation, reversing effects of neuromuscular blocking drugs during surgery, treatment of submental fat, and management of acute pain.