2007 Manufacturing Patients Provider 
The Health Policy Exchange
MAY 20, 2013
Food and Drug Administration to market a new drug is a critical waypoint along the path to profits for pharmaceutical manufacturers. Unfortunately, recent case studies have illustrated that FDA approval does not necessarily provide assurances of effectiveness and safety. Approval from the U.S. Could the FDA and other U.S.
FDA Law Blog
AUGUST 21, 2023
After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. Just like it was over a decade ago in Pliva v. FDA, for years, has been concerned with overwarning.
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