As of October 31, 2004
Numbers reflect the number of drugs (i.e., active moiety) per sponsor.
Review Division |
Proposed Pediatric Study Requests (PPSRs) Received |
Written Requests Issued * |
---|---|---|
Cardio-Renal Drug Products (HFD-110) |
37 |
32 |
Neuropharmacological Drug Products (HFD-120) |
50 |
40 |
Oncology Drug Products (HFD-150) |
20 |
30 |
Medical Imaging and Radiopharmaceutical Drug Products (HFD-160) |
4 |
0 |
Anesthetic, Critical Care, and Addiction Drug Products (HFD-170) |
22 |
16 |
Gastro-Intestinal and Coagulation Drug Products (HFD-180) |
32 |
20 |
Metabolic and Endocrine Drug Products (HFD-510) |
59 |
38 |
Anti-Infective Drug Products (HFD-520) |
5 |
2 |
Anti-Viral Drug Products (HFD-530) |
25 |
29 |
Dermatologic and Dental Drug Products (HFD-540) |
22 |
13 |
Anti-Inflammatory, Analgesic, and Ophthalmologic Drug Products (HFD-550) |
33 |
39 |
Over-the-Counter Drug Products (HFD-560) |
6 |
3 |
Pulmonary Drug Products (HFD-570) |
17 |
17 |
Reproductive and Endocrine Drug Products (HFD-580) |
11 |
3 |
Special Pathogen and Immunologic Drug Products (HFD-590) |
16 |
13 |
TOTAL |
359 |
295 |
Numbers reflect the number of drugs (i.e., active moiety) per sponsor.
TOTAL Actions
240 Written Requests with PPSRs
55 Written Requests without PPSRs
172 Incomplete Responses
12 PPSR Withdrawal
7 Written Request Withdrawal
278 Written Request Amendments
TOTAL = 764
*This column will never equal the number of proposals submitted, because a Written Request may be issued without a proposal, and a proposal may result in an action that is incomplete instead of a Written Request. Back to top of table
Last Updated: October 6, 2004