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  5. FDA-TRACK: FY18 Web Results
  1. Transparency

Cumulative FDA-TRACK Subscribers

 Fiscal Year  Cumulative Subscribers*
 FY18 53,131
 FY17  48,640
 FY16  42,293
 FY15  31,149
 FY14  21,998
 FY13  14,519
 FY12  8,620
 FY11 4,669
 

Top Measures Viewed in FY18

 

1. CDER: Number of Fast Track designations granted, Accelerated Approval, Priority Reviews, and First Generics

2. CDER: Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submitted and approved

3. CBER: Number of Breakthrough Therapy Designation Requests Received

4. OIP: Total number of inspections completed by investigators based in-country in the month 

5. CDER: Number of New Molecular Entity (NME) NDAs and new BLAs submitted and approved 

*In September 2017, the FDA transitioned to a new marketing platform, Oracle Eloqua. During the transition process, each of FDA's subscriber databases were scrubbed to better reflect actual subscriber information. This more accurate data of FDA-TRACK subscribers will be used moving forward.

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