"Least burdensome" premarket review
This article was originally published in The Gray Sheet
Executive SummaryJan. 4 meeting between FDA and industry reps will include discussion of the FDA Modernization Act's mandate that the agency require the least burdensome review of premarket submissions ("The Gray Sheet" Dec. 14, p. 3). The meeting will take place from 1:00-4:00 p.m. at CDRH's Corporate Building. Those interested in attending should contact FDA's Cathy Hobbs at 301/594-2022
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