Brand and Generics Companies Unite to Pressure FDA: They Want the Agency to Drop Its Safety-Label Plan and Adopt Their Alternative.
نویسنده
چکیده
Fear of lawsuits and customer confusion have greeted a Food and Drug Administration plan to let generic drug companies change labels quickly, without prior agency approval, when they learn of adverse effects once the generic reaches the market.
منابع مشابه
A shift on "pay for delay"--reopening doors for pharmaceutical competition?
by approved drugs is funded by the manufacturers — a situation that can lead to problems with the collection, analysis, and reporting of safety data.4 Finally, this alternative approach would be in keeping with a stronger, better-managed role for the FDA in monitoring drug side effects. A similar approach could also be used to create a fund for compensating patients injured by adverse events th...
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ورودعنوان ژورنال:
- P & T : a peer-reviewed journal for formulary management
دوره 40 8 شماره
صفحات -
تاریخ انتشار 2015