Supreme Court Amicus Brief Regarding Wyeth v. Diana Levine [PDF]
Prominent in arguments opposing preemption of state tort law liability for alleged inadequacies in prescription drug labeling is the argument that such liability can complement FDA regulation by improving on a regulatory scheme that fails to provide ...
Berndt, Ernst R. +5 more
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Gene-silencing technology gets first drug approval after 20-year wait
Nature, 2018 Heidi Ledford
semanticscholar +1 more source
US drug companies will meet more than half the cost of drug approval
, 2002 D. Josefson
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United States Food and Drug Administration Approval Summary: Bortezomib for the Treatment of Progressive Multiple Myeloma after One Prior Therapy [PDF]
, 2006 Robert C. Kane +3 more
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Advances on anticancer new drugs in China and the USA in 2020: from ongoing trial to drug approval. [PDF]
J Natl Cancer Cent, 2021 Huang H +10 more
europepmc +1 more source
Current guidelines applicable for the approval of dermatological drugs
, 2002 A Zesch
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A Proposal for Radical Changes in the Drug-Approval Process [PDF]
, 2006 Alex Philchenkov
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Re-examining our approach to the approval and use of new drugs [PDF]
, 2006 S. K. Lee
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Cooperative research and development opportunities with the National Cancer Institute [PDF]
The Office of Technology Development (OTD) of the National Cancer Institute (NCI) is responsible for negotiating Cooperative Research and Development Agreements (CRADAs), whereby the knowledge resulting from NCI investigators' government-sponsored ...
Sybert, Kathleen
core +1 more source
Informing prospective research subjects of the influence of regulatory requirements for drug approval on the design of clinical trials in oncology [PDF]
, 2007 Maurie Markman
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