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  1. Transparency

FDA-TRACK: Office of Special Medical Programs Dashboard

FDA-TRACK: Office of Special Medical Programs Dashboard

FDA's Office of Special Medical Programs (OSMP) includes:

  1. Office of Combination Products (OCP) – OCP serves as a focal point for combination product (drug-device, biologic-device, drug-biologic, or drug-device-biologic products) issues for agency reviewers and industry. The office is responsible for ensuring the prompt assignment of combination products (drug-device, biologic-device, drug-biologic, or drug-device-biologic products) to FDA Centers, the timely and effective premarket review of such combination products, and consistent and appropriate postmarket regulation of these products.
  2. Office of Good Clinical Practice (OGCP) - OGCP is the focal point for Good Clinical Practice (GCP) and Human Subject Protection (HSP) issues related to FDA-regulated clinical trials. OGCP sets priorities for the development of HSP and Bioresearch Monitoring (BIMO) policy, advises FDA's Centers and the Office of Regulatory Affairs (ORA) on GCP and HSP policy, participates in international GCP harmonization activities, and serves as the liaison to other federal agencies and external stakeholders committed to the protection of human research participants.
  3. Office of Orphan Products Development (OOPD) – OOPD is dedicated to promoting the development of products (drugs, devices, biologics, and medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. OOPD interacts with the medical and research communities, professional organizations, academia, the pharmaceutical industry, and rare disease patient groups. OOPD administers the major provisions of the Orphan Drug Act (ODA) which provide incentives for sponsors to develop products for rare diseases.
  4. Office of Pediatric Therapeutics (OPT) – OPT’s primary mission is to assure access for children to innovative, safe and effective medical products. Historically, many medical products have not been tested for use in children, leading to an increase in adverse events and the use of ineffective products. Given its legislative mandate, OPT has developed interrelated programs to support FDA efforts to improve information on pediatric therapeutics.

Each FDA-TRACK program area collects, analyzes, and reports its performance measures and results. Explore the progress OSMP is making towards it's goals below:

I. Guidances and Regulations Development

Measures are under development and will be available once finalized.

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

  3. Percentage of informal requests issued within 60 days

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

Measures are under development and will be available once finalized.

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 direct and consult requests received in the month

  2. Percentage of 60-day statutory deadlines met for RPD designation requests in the month

  3. Total number of RPD direct and consult requests 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

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 in the month

  2. Number of internal meetings that are used to plan external meetings in the month

  3. Number of international outreach efforts in the month

  4. Number of publications in the month

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 of internal and external safety and product assessment meetings in the month

  2. Number of Literature Reviews completed in the month

  3. Number of medical products studied in children with labeling changes in the month

  4. Number of conflict of interest (COI) matters completed in the month

  5. Federal Register (FR) Notices:

a. Number of FR Notices published in the month

b. Number of FR Notices amended in the month

  6. Logistical Activities:

a. Number of contracts drafted in the month

b. Number of contracts amended in the month

c. Number of meeting travel authorizations created in the month

d. Number of meeting travel vouchers granted in the month

  7. Number of personnel actions for Special Government Employees (SGEs) and Pediatric Advisory Committee (PAC) Members in the month

  8. Pediatric Advisory Committee (PAC) Activities:

a. Number of additional experts contacted in the month

b. Number of PAC Meetings held in the month

c. Number of PAC Meeting days in the month

d. Number of PAC Joint Meetings with other divisions in the month

e. Number of 50.54 Meetings in the month

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

a. Number of activities in the month

b. Number of Neonatal-Perinatal Medicine consultations or reviews in the month

c. Number of Pediatric Ethics consultations or reviews in the month

d. Number of meetings to develop or revise pediatric/ethics guidance in the month

III. Pediatric Collaboration Measures

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

1. Number of oral communications, including meetings, with foreign regulators to discuss issues related to pediatric products development 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 Pediatric Review Committee's (PeRC) products/requested by FDA divisions in the month

2. Number of EMA  Pediatric Investigation Plans (PIPs) that are matched with Oncology Subcommittee of PeRC products/requested by FDA divisions in the month

Completed Measures and Key Projects

Note:  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.

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