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FDA-TRACK Office of Special Medical Programs Dashboard

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Contents:

Note: Information is as of June 30, 2016. The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.

Office of Special Medical Programs

I. Guidances and Regulations Development

A. Improve public health by clearly communicating to our external constituencies the practices, recommendations, and requirements of policies and programs overseen by OSMP

  1. Number of guidances and regulations issued and in clearance

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Office of Combination Products

I. Request for Designation (RFD) Processing Measures

A. Ensure filed RFDs are reviewed within statutorily mandated 60 day timeframe

  1. Percentage of RFD decisions issued in the month reviewed within 60 days
  2. Total number of RFDs filed by OCP in the month

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Office of Orphan Products Development (OOPD)

I. Orphan Drug Designation Application Review Time Measures

A. Ensure timely review of orphan drug designation applications

  1. Total number of orphan drug designation reviews completed in the month
  2. Total number of orphan drug designation requests received in the month
  3. Percentage of orphan drug designation reviews completed in 120 days or less
  4. Total number of orphan drug designation decisions that resulted in orphan designation in the month
  5. Total number of orphan drug approvals in the month

II. Humanitarian Use Device (HUD) Designation Application Review Time Measures

A. Ensure timely review of HUD designation applications

  1. Total number of HUD designation reviews completed in the month
  2. Total number of HUD designation requests received in the month
  3. Percentage of HUD designation reviews completed in 45 days or less
  4. Total number of HUD decisions that resulted in HUD designation in month

III. Pediatric Device Consortia (PDC) Grant Program Measures

A. Promote through PDC grants the development, production and distribution of needed medical devices for children

  1. Cumulative number of pediatric devices that have been provided assistance by the Pediatric Device Consortia

IV. Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) Program Measures

A. To track workload and ensure timely review of RPD requests

  1. Total number of RPD requests (designations and consults) received in the month
  2. Percentage of 60-day statutory deadlines met for RPD designation requests in the month
  3. Total number of RPD requests (designation and consults) granted in the month

V. Orphan Products (Clinical Trials) Grants Program Measures

A. Encourage clinical development of products for use in rare diseases or conditions

  1. Total number of grant applications received (February and October submission dates)
  2. Total number of grant panels convened (April through June and November through January)
  3.  Total number of grants awarded per month
  4. Estimated average number of reports received for active grants per month

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Office of Pediatric Therapeutics (OPT)

I. Outreach Measures

A. Improve public health by increasing transparency and educational outreach

  1. Number of presentations/participation at U.S. conferences, stakeholder meetings, and trainings during the month
  2. Number of international outreach efforts during the month
  3. Number of publications

II. Pediatric Medical Product Safety Measures

A. Provide a public assessment of post-marketing safety information for products studied in the pediatric population in an effort to enhance the understanding of safety issues that arise when products are used in a much broader manner in children than the limited exposures seen in pediatric trials

  1. Number internal safety and product assessment meetings in the month
  2. Number of medical products studied in children with labeling changes in the month
  3. Number of Pediatric Advisory Committee (PAC) related activities in the month

B. Scientific development activities (e.g. PAC, KIDNET, consortium, grant administration)

  1. Number of activities
  2.  Number of Neonatal-Perinatal Medicine consultations or reviews

III. Pediatric Collaboration Measures

A. Enhance scientific content, ethical conduct and safety of pediatric trials in collaboration with international regulatory bodies

  1. Number of contacts and meetings with foreign regulators to discuss scientific, ethical or safety issues related to pediatrics in the month

B. Enhance scientific content, ethical conduct and safety of international pediatric trails in collaboration with FDA colleagues

  1. Number of EMA  Pediatric Investigation Plans (PIPs) that are matched with PeRC's products/requested by FDA divisions 

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Page Last Updated: 10/31/2016
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