In our June/July issue:
PEER-REVIEWED ARTICLES
Using 505(b)(2) to Solve Shortfall from Generic Cliff
Ken Phelps
This article explores how to go through the FDA’s 505(b)(2) application process, which allows companies to file new drug applications (NDAs) utilizing some pivotal data already existing in the public domain.
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Lifecycle Modeling and Simulation in Clinical Trials
Andrew Garrett, Michael O'Kelly, Davis Walp, N. Seth Berry
How the applications of evolving M&S models are transforming full-research design strategies.
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The U.S. Biosimilar Pathway: Policy Precedes Science
David Shoemaker, PhD
A regulatory perspective on the current state of protein science and the implications for biosimilar approval.
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Managing Portfolios to Deliver Economic and Clinical Value
Rita E. Numerof, PhD, Jill E. Sackman, DVM, PhD, Michael J. Kuchenreuther, PhD
The importance of focusing on both outcomes as early as possible in the product development cycle.
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NEWS
View From Washington: Jill Wechsler reports on how legislative initiatives are impacting the FDA financially and how they can support these faster reviews.
View From Brussels: Peter O’Donnell reports on the EMA’s annual report and its regulatory vision for Europe.
Global Report: Philip Ward highlights global pressure to support antibiotic research.
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CLINICAL TRIAL INSIGHTS
Characterizing the Real Cost of Site Regulatory Compliance
Ken Getz
A new study examines the financial and resource burden for sites in managing regulatory compliance. |
CLOSING THOUGHT
Safety Considerations for Follow-On Non-Biologic Complex Drugs
Scott Kolodny, MD
A follow on NBCD may have difficult-to-detect differences from the original drug that cause serious safety problems that only come to light after the drug is marketed. |
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If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - [email protected]
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