Practical, legal, and ethical issues in expanded access to investigational drugs
The authors review the FDA policies and procedures that permit some patients with serious conditions to receive investigational drugs before formal product approval and examine the legal and ethical issues associated with expanded access..
| Medienart: |
Artikel |
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| Erscheinungsjahr: |
2015 |
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| Erschienen: |
2015 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:372 |
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| Enthalten in: |
The New England journal of medicine - 372(2015), 3, Seite 279-286 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Darrow, Jonathan J [VerfasserIn] |
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| Links: |
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| RVK: |
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| doi: |
10.1056/NEJMhle1409465 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 520 | |a The authors review the FDA policies and procedures that permit some patients with serious conditions to receive investigational drugs before formal product approval and examine the legal and ethical issues associated with expanded access. | ||
| 650 | 4 | |a Health Services Accessibility - legislation & jurisprudence | |
| 650 | 4 | |a Drug Approval - history | |
| 650 | 4 | |a Health Policy - legislation & jurisprudence | |
| 650 | 4 | |a Government Regulation - history | |
| 650 | 4 | |a Health Services Accessibility - ethics | |
| 650 | 4 | |a Drugs, Investigational - history | |
| 650 | 4 | |a Drugs, Investigational - therapeutic use | |
| 650 | 4 | |a Drug Approval - legislation & jurisprudence | |
| 650 | 4 | |a Risk assessment | |
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| 650 | 4 | |a Drug approval | |
| 650 | 4 | |a Ethical aspects | |
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