Statistics, or How to Meet FDA Requirements


In 1994, the Food and Drug Administration (FDA) released the Tentative Final Monograph (TFM) requiring a product’s average reductions to meet the log10 reduction requirements.  Later, they changed this to the lower bounds of the 95% confidence intervals.  Then they added the 70% responder rates. Both test and control products must meet 70% responder rates, which creates a major obstacle. Now, the common control products cannot meet requirements. The industry has pushed back through the American Cleaning Institute. 


As a result, the FDA has presented more reasonable requirements:
  • Test product is non-inferior to Control Product
  • Test product is superior to Vehicle Product 
How can firms in the industry successfully meet FDA requirements?

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