Applied Clinical Trials Direct
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  October 29, 2012

In This Edition
News Roundup: EMA to Meet Business Targets
Feature Articles: FDA Warning Letter Study
Blog Posts: Implications of Biosimilar Development

News Roundup
bullet EMA On Track to Meet Core Business Targets for 2012
bullet Vivus Wants REMS Amended for Qysmia
bullet Partnership for Expanded Publishing and Submission of Reg Docs
bullet Regulators Must Modify Approach
bullet News from RAPS

Feature Interview
bullet FDA Warning Letter Study
bullet Developing Quality Biosimilars

Blogs Posts
bullet Conflict of Interest at EMA
bullet Implications of Biosimilar Development
bullet Are Cardiovascular Problems Ever Not a Risk?
 
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Ask The Editor

Lisa Henderson
Editor in Chief [email protected]

Webcasts & Events
bullet FDA Meeting of the Drug Safety and Risk Management Advisory Committee,
October 29 and 30
bullet CBI's Life Sciences Forum on GCP Compliance and Quality Oversight
bullet CBI's 4th Annual Effective Preparation for FDA Advisory Committee Meetings