Applied Clinical Trials
June 01, 2015
News
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Agency concerned about how proposals in "Cures" bill will be crafted and implemented.
June 01, 2015
A Closing Thought
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6
With patents for many NBCDs soon to expire, the need for regulatory guidance regarding follow-on versions of these products is crucial.
June 01, 2015
View from Brussels
24
6
The tone of agency’s annual report contrasts its recent candid stance on regulatory vision for Europe
June 01, 2015
News
24
6
Study finds that almost 75% of cancer drug candidates rely on biomarker data.
June 01, 2015
CTI Insights
24
6
Study takes rare look at the financial and resource burden for sites in managing regulatory compliance.
June 01, 2015
Feature Article
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6
Understanding the benefits of this application route in helping companies withstand the hit of patent expiries.
June 01, 2015
Feature Article
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How the application of evolving M&S models are transforming full-research design strategies.
June 01, 2015
Feature Article
24
6
A regulatory perspective on the current state of protein science and the implications for biosimilar approval.
June 01, 2015
Issue PDF
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Regulatory: Solving Generic Cliff with 505(b)(2) The U.S. Biosimilar Pathway Trial Design: Modeling & Simulation Strategies Lifecycle Management: Bridging Economic & Clinical Value Also in this issue: EMA's Dueling Tones on Regulatory Vision Regulatory Compliance: The Site Burden Assessing Safety for Follow-on NBCDs