FDA's Chicken Or Egg Question For Pharmacy Leaflets: Should Benefit Or Risk Come First?
FDA will look at which should come first – benefits or risks – when it studies patients' response to three one-page prototypes of patient medication information.
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FDA “Reminds” Doctors To Talk About Drug Benefits
Proposed pilot program would look for the best patient counseling practices, but can FDA remind providers to discuss a drug’s benefits without actually specifying them?
Whose Burden Is It Anyway? REMS’ Health Care Impact Belongs To FDA, PhRMA Says
Industry group contends that FDA should assess whether a REMS places an undue burden on the health care industry – because asking companies to do that evaluation would be an additional burden on the health care system.
Electronic Labeling Study By GAO Yields “No Consensus,” Avoids Cost Issue
In study mandated by FDASIA, GAO says there are advantages and disadvantages to switching to an electronic-only system for distributing drug label information, but offers no conclusions.