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Expanded access rules pose quandary for drug developers

Nature Biotechnology volume 27, pages 871–872 (2009)Cite this article

Expanded access rules have been in effect in the US since 1987, when the sluggish pace of drug approvals to address the emerging HIV/AIDS epidemic brought the wrath of activists and advocates down on industry, the FDA and the US Congress. Although big pharma typically has programs in place to help patients to access drugs that have yet to be approved by the FDA in similar crisis situations, smaller companies (especially startup companies), often have limited resources and offer expanded access on the basis of altruism and goodwill toward patients.

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  1. George S. Mack, Columbia, South Carolina. With additional reporting by Malorye Allison, Acton, Massachusetts.

    George S Mack

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  1. George S Mack
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Mack, G. Expanded access rules pose quandary for drug developers. Nat Biotechnol 27, 871–872 (2009). https://doi.org/10.1038/nbt1009-871

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