Applied Clinical Trials-06-01-2015

News
Applied Clinical Trials

June 01, 2015

Agency concerned about how proposals in "Cures" bill will be crafted and implemented.

Applied Clinical Trials

With patents for many NBCDs soon to expire, the need for regulatory guidance regarding follow-on versions of these products is crucial.

Applied Clinical Trials
View from Brussels

June 01, 2015

The tone of agency’s annual report contrasts its recent candid stance on regulatory vision for Europe

News
Applied Clinical Trials

June 01, 2015

Applied Clinical Trials

Study finds that almost 75% of cancer drug candidates rely on biomarker data. 

Applied Clinical Trials

Study takes rare look at the financial and resource burden for sites in managing regulatory compliance.

Applied Clinical Trials

Understanding the benefits of this application route in helping companies withstand the hit of patent expiries.

Applied Clinical Trials

How the application of evolving M&S models are transforming full-research design strategies.

Applied Clinical Trials

A regulatory perspective on the current state of protein science and the implications for biosimilar approval.

Applied Clinical Trials

 

Issue PDF
Applied Clinical Trials

June 01, 2015

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