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 |
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| container_title | Nature reviews. Drug discovery |
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| creator | Hunter, Nina L. Rao, Gayatri R. Sherman, Rachel E. |
| description | 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. |
| doi_str_mv | 10.1038/nrd.2017.151 |
| format | Article |
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Drug discovery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hunter, Nina L.</au><au>Rao, Gayatri R.</au><au>Sherman, Rachel E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Flexibility in the FDA approach to orphan drug development</atitle><jtitle>Nature reviews. Drug discovery</jtitle><stitle>Nat Rev Drug Discov</stitle><addtitle>Nat Rev Drug Discov</addtitle><date>2017-11-01</date><risdate>2017</risdate><volume>16</volume><issue>11</issue><spage>737</spage><epage>738</epage><pages>737-738</pages><issn>1474-1776</issn><eissn>1474-1784</eissn><abstract>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.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>28860647</pmid><doi>10.1038/nrd.2017.151</doi><tpages>2</tpages></addata></record> |
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| subjects | 631/154/155 631/208/1516 692/308/153 692/699 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 |
| title | Flexibility in the FDA approach to orphan drug development |
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