Flexibility in the FDA approach to orphan drug development

Flexibility in the FDA approach to orphan drug development

Scientific advances, in combination with government incentives and commercial opportunity, have fuelled strong investment in orphan drugs, resulting in many innovative therapies. Here, we discuss the approach of the FDA to a range of issues that remain crucial to maintaining this momentum, such as t...

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Veröffentlicht in:Nature reviews. Drug discovery 2017-11, Vol.16 (11), p.737-738
Hauptverfasser: Hunter, Nina L., Rao, Gayatri R., Sherman, Rachel E.
Format: Artikel
Sprache:eng
Schlagworte:
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Biological products
Biomedical and Life Sciences
Biomedicine
Biotechnology
Cancer Research
comment
Drug approval
Drug Approval - methods
Drug development
Drug Development - methods
Drug Development - trends
FDA approval
Generic drugs
Humans
Laws, regulations and rules
Licensing, certification and accreditation
Medicinal Chemistry
Molecular Medicine
Mutation
Orphan Drug Production - methods
Orphan drugs
Pharmacology/Toxicology
Product development
Rare Diseases - drug therapy
United States
United States Food and Drug Administration
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Beschreibung
Zusammenfassung:Scientific advances, in combination with government incentives and commercial opportunity, have fuelled strong investment in orphan drugs, resulting in many innovative therapies. Here, we discuss the approach of the FDA to a range of issues that remain crucial to maintaining this momentum, such as the use of the totality of evidence in evaluating orphan drugs. Scientific advances, in combination with government incentives and commercial opportunity, have fuelled strong investment in orphan drugs, resulting in many innovative therapies. Here, we discuss the approach of the FDA to a range of issues that remain crucial to maintaining this momentum, such as the use of the totality of evidence in evaluating orphan drugs.
ISSN:1474-1776
1474-1784
DOI:10.1038/nrd.2017.151