Biogenerics at the crossroads
Article Abstract:
Two executives from a leading generics manufacturer and a leading brand manufacturer have given their views on implementing an abbreviated US regulatory framework for the approval of biogeneric products. The products would be eligible for competition from generic biopharmaceuticals if an approval process existed.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2006
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The FDA animal efficacy rule and biodefense
Article Abstract:
The U.S. Food and Drug Administration (FDA) Animal Efficacy Rule ('the Rule') need to be implemented to facilitate the development of medical countermeasures for bioterrorism. The members of the Alliance for Biosecurity provide three major recommendations for implementing the Rule.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2007
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