Statistics, or How to Meet FDA Requirements - Bioscience Labs
1765 South 19th Ave Bozeman, MT    

Statistics, or How to Meet FDA Requirements

Posted On: Apr 26, 2017

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?

Click here for full article