A regulatory perspective on in vitro diagnostics
Article Abstract:
The Food and Drug Administration (FDA) is developing a guidance document that will outline the approach for concurrent development of both a new drug and a corresponding in Vitro Diagnostic device (IVD) for use in decision-making about drug selection for patients in clinical practice. The development of a cooperative framework among regulators, product sponsors and technology experts would be required for revolutionary promise that these platforms caould have on the evolution of drug development, regulatory science, the practice of medicine and public health.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2006
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No room for experiment: the federal circuit's narrow construction of the experimental use defense
Article Abstract:
American educational and research institutions have deflected suggestions that their research activities run afoul of in-force patents by pointing to the so-called experimental use doctrine. The doctrine established by court decisions held that activities undertaken without any intent to derive profits or practical advantage do not constitute patent infringement.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2003
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Proposed changed to patent codes loom over biotech industry
Article Abstract:
The US District Court for the Eastern District of Virginia issued an order against the suggested changes to the US patent code after London-based GlaxoSmithKline (GSK) filed a suit against the US Patent and Trademark Office (USPTO).
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2007
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