Thursday, September 19, 2019

Thursday, September 19, 2019

FDA Update: electronic submissions statistics


Pexels.com

Electronic regulatory submissions sent to the U.S. Food and Drug Administration have increased year-by-year since the electronic system was launched in 2009, the FDA reports.

The agency’s Electronic Submissions Gateway offers a secure entry point for companies and FDA partners to send documents containing premarket and post-market regulatory information on pharmaceuticals and medical products, according to the FDA.

The system has increased regulatory efficiency, reduced paper document submissions and greatly reduced shipping expenses, the FDA said.

---

Electronic Submissions Gateway Total Submission Statistics

Submission Types20092010201120122013201420152016201720182019Totals
Adverse Event Reporting System300,672472,142557,917717,345876,4751,026,3141,321,1141,533,3781,698,0942,118,8271,304,62711,926,905
Center for Drug Evaluation and Research45,51069,73993,503107,681124,232139,322159,515165,932189,141221,471136,1471,452,193
Center for Biologics Evaluation and Research4,4835,5886,3976,9278,4129,50611,29420,27852,19756,04439,588220,714
Center for Devices and Radiological Health21,296119,087280,312462,316666,927812,4431,478,5242,032,7671,921,8712,247,2861,470,39611,513,225
Center of Veterinary Medicine8592,08320,46237,92840,97844,60752,60164,19770,43670,68242,802447,635
Office of the Commissioner16,27548,23255,67664,28565,43068,17160,94356,51771,54577,35334,009618,436
Center for Tobacco Products52233486421,23732473461223,98419,1422,03549,286
Affordable Care Act

622071952122282182362641,622
Generic Drug User Fee Amendments

2,7712,9263,5472,9061,6441,6001,4551,11317,962
Center for Food Safety and Applied Nutrition

4584,2202,7563,7613,6192,6612,4211,43021,326
Health Canada

3245,8359,36616,49723,59526,92716,28998,833
Totals389,100717,0941,014,6151,400,4151,791,3682,113,0203,100,9703,895,6694,055,3424,841,8443,048,70026,368,137
Source: U.S. Food and Drug Administration

Organizations in this Story

U.S. Food and Drug Administration (FDA)

More News

FDA Reporter