Statistics, or How to Meet FDA Requirements

In 1994, the Food and Drug Administration (FDA) released the Tentative Final Monograph (TFM) requiring the product’s average reductions to meet the log10reduction 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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