کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
8663249 1576531 2018 12 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Expanding Patient Access to Investigational New Drugs
ترجمه فارسی عنوان
گسترش دسترسی بیمار به داروهای جدید تحقیقاتی
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی کاردیولوژی و پزشکی قلب و عروق
چکیده انگلیسی
Individual patients with life-threatening or severely debilitating diseases can petition the U.S. Food and Drug Administration (FDA) through their physicians to have expanded access (EA) to drugs that are in clinical trials but have not reached full FDA approval (the “single-patient” investigational new drug [IND] application). Additionally, recent state and federal laws-so-called “right to try legislation”-allow patients to approach drug companies directly for access prior to FDA approval. While these pathways provide potential access for individual patients to investigational drugs, different EA pathways permit entire groups of certain patients to access investigational drugs prior to FDA approval. This review focuses on special categories of EA INDs intended for multiple patients-the intermediate-group IND and the widespread-treatment IND-as well as emergency authorization for use of investigational drugs and biological products (e.g., vaccines) in public health emergencies.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: JACC: Basic to Translational Science - Volume 3, Issue 3, June 2018, Pages 403-414
نویسندگان
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