کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
8663267 1576532 2018 14 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Expanding Patient Access to Investigational Drugs
ترجمه فارسی عنوان
گسترش دسترسی بیمار به داروهای تحقیقاتی
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی کاردیولوژی و پزشکی قلب و عروق
چکیده انگلیسی
With drug approval times taking an average of 8 years from entry into clinical trials to full U.S. Food and Drug Administration (FDA) approval, patients with life-threatening and severely debilitating disease and no reasonable therapeutic options are advocating for expanded access (EA) to investigational drugs prior to approval. Special investigational new drug (IND) application categories allow patients who meet specific criteria to receive treatment with non-approved drugs. The FDA approves over 99% of all single-patient INDs, providing emergency approval within hours, and non-emergency approval within an average of 4 days. “Right-to-try” laws passed in 38 states would allow patients to bypass FDA processes altogether, but contain controversial provisions that some claim risk more harm than benefit to desperate and vulnerable patients. This review focuses on FDA EA to non-approved drugs through a special category of IND-the single-patient IND-and “right-to-try” (R2T) access outside of the FDA.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: JACC: Basic to Translational Science - Volume 3, Issue 2, April 2018, Pages 280-293
نویسندگان
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