Review Division Proposed Pediatric Study Requests (PPSRs) Received Written Requests Issued *
DCRP (Division of Cardiovascular Renal Products) 70 44 Updated
DNP (Division of Neurology Products 64 Updated 28 
DPP (Division of Psychiatry Products) 54 Updated  37  
DOP1 (Division of Oncology Products 1) 31 Updated 21 
DOP2 (Division of Oncology Products 2) 22 Updated 15 Updated
DHP (Division of Hematology Products) 48 Updated 20 Updated
DHOTP (Division of Hematology Oncology Toxicology Products)   0  0
DMIP (Division of Medical Imaging Products) 19 Updated 7
DAAP (Division of Analgesia, Anesthesia, and Addiction Products)  75 Updated 39 
DGIEP (Division of Gastroentereology and Inborn Products)  53  23 
DMEP (Division of Metabolism and Endocrinology Products)   99   39  
DAIP (Division of Anti-Infective Products) 18 Updated  4  
DAVP (Division of Anti-Viral Products)  51 Updated   42 
DDDP (Division of Dermatology and Dental Products)  41   18 
DNCE (Division of Nonprescription Evaluation) 8 5
DNRD (Division of Nonprescription Regulation Development) 0 0
DPARP (Division of Pulmonary, Allergy and Rheumatology Products)  41    23  
DRUP (Division of Reproductive and Urologic Products)  34   13 
DTOP (Division of Transplant and Ophthalmology Products) 43  50 
TOTAL
771 Updated
428 Updated  

 

Numbers reflect the number of drugs (i.e., active moiety) per division.

TOTAL Actions

 

349 Updated  Written Requests with PPSRs

 

  79   Written Requests without PPSRs

 

360 Updated  Incomplete Responses  

 

  26   PPSR Withdrawals

 

    9   Written Request Withdrawals

 

502  Written Request Amendments

 

TOTAL = 1325 Updated

 

* 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.

New/Transfers – some PPSRs/WRs were transferred to other divisions which are organized by therapeutic area within the Pediatric Exclusivity database.

 

Posted on the FDA website on 10 January 2013