Prepare More Data Earlier For Advisory Panels In Era Of Low Risk-Tolerance
This article was originally published in The Tan Sheet
A stricter risk-tolerance environment at FDA means sponsors need to engage more in the advisory committee process and prepare to address real and perceived or hypothetical "data gaps.
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Recognizing that planning and conducting advisory committee meetings can be "traumatic" for both government and industry, FDA is taking steps to improve the process, said Charles Ganley, the head of the agency's OTC drugs program
An FDA advisory panel decided in split votes Oct. 19 to recommend immediately that all OTC cough/cold medicines should not be used for 2-to 5-year-old children but are safe for 6- to 12-year-olds
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