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CDER’s Office of Compliance Issues CY 2018 Report

The Report issued each year by the Office of Compliance (OC) is a treasure trove of facts and figures espousing the accomplishments of the OC.  The 32 page document (which can be found here) provides a detailed account of OC actions in the enforcement arena, guidance area, consumer awareness and education area, actions relative to opioids, safety, health and product warnings including unapproved drugs and dangerous “dietary supplements”, and keeping dangerous medications from entering the United States market.

Some interesting factoids from the report include the fact the OC:

  • Held three public meetings related to compounding
  • Issued 23 draft and final guidances
  • Assisted in the mitigation of drug shortages for 52 drugs by exercising regulatory flexibility in 79 instances
  • Oversaw Good Clinical Practice Inspections for over 130 NDA and BLA
  • Coordinated 24 recalls for the “sartan” products
  • Issued 174 facility classification letters under the GDUFA commitment
  • Issued 84 warning letters

There is a section entitled Compliance by the Numbers with some dandy charts and tables – one example is a table for the number of recalls produced below.

The report is an easy read and provides lots of useful information.