Compounding Pharmacists Unhappy With New FDA Guidance Documents : Rules Severely Limit Distribution.
نویسنده
چکیده
Recent FDA compounding guidances raise hackles.
منابع مشابه
Explanations and unresolved issues pertaining to the development of the Nuclear Pharmacy Compounding Guidelines.
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n engl j med 367;21 nejm.org november 22, 2012 1969 requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting humanresearch subjects owe a debt to Tuskegee and Nuremberg. Sometimes it takes a disaster to spur the adoption ...
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ورودعنوان ژورنال:
- P & T : a peer-reviewed journal for formulary management
دوره 41 8 شماره
صفحات -
تاریخ انتشار 2016