Pharmacists, Deluged With Requirements, Pressure FDA to Standardize REMS Programs.
نویسنده
چکیده
Pharmacists want the FDA to standardize REMS programs.
منابع مشابه
The Food and Drug Administration Amendments Act of 2007: drug safety and health-system pharmacy implications: introduction.
PURPOSE To describe the drug safety provisions of the Food and Drug Administration Amendments Act (FDAAA) of 2007, including risk evaluation and mitigation strategies (REMS), and the implications for health-system pharmacists. SUMMARY The FDAAA grants FDA new authorities to require postmarketing studies or clinical trials of human drugs and to require REMS. The REMS provisions of the FDAAA re...
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ify higher fees for drug companies; however, revamping REMS won’t be the only issue. Pharmacists are concerned about another FDAAA provision: the FDA’s creation of an active Sentinel adverse reaction alert system, meant to supplement its existing passive MedWatch system, which has been roundly criticized for its shortcomings. In fact, both Democrats and Republicans, often at the behest of speci...
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ورودعنوان ژورنال:
- P & T : a peer-reviewed journal for formulary management
دوره 39 1 شماره
صفحات -
تاریخ انتشار 2014