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Last Updated Thursday, May 23 2013
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Topics - Regulatory Affairs


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Published May 8, 2013
To provide regulatory consulting and product registration services Read More »
By Gil Roth
Published January 23, 2013
Will manufacture, distribute more than 100 products while continuing remediation Read More »
By Ed Silverman, Contributing Editor
Published January 22, 2013
Off-label promotion or free speech? Read More »
By Colleen Heisey, J.D., M.P.H., Hunton & Williams LLP
Published January 22, 2013
FDA revises draft guidance document to address industry comments Read More »
Global API Inspections
By Tony Scott, European Fine Chemicals Group
Published January 22, 2013
Can Mutual Recognition Agreements ensure safety? Read More »
Published January 4, 2013
Aims to satisfy the Sunshine Provisions Read More »
Published January 2, 2013
Expands regulatory capabilities with InSight platform Read More »
By Gil Roth
Published December 12, 2012
Morris appointed to Clinical Technologies executive team Read More »
By Ed Silverman, Contributing Editor
Published November 9, 2012
Could a meningitis outbreak have been prevented? Read More »
By Colleen Heisey, J.D., M.P.H. and Sharon M. Bradley, J.D., Hunton & Williams LLP
Published November 9, 2012
Self-identification under the Generic Drug User Fee Amendments Read More »
Pharmaceutical Quality Systems
By Neil J. Wilkinson, NSF-DBA
Published November 9, 2012
ICH Q10 standard ushers in a new era of quality culture Read More »
Are You Gambling With Your Next Inspection?
By Julie Larsen, BioTeknica, Inc.
Published November 9, 2012
10 Key Questions to Assess Inspection Readiness Read More »
Regulatory Affairs For Components
By Debbie Thomas and Steve LoCastro, West Pharmaceutical Services, Inc.
Published November 9, 2012
Building stronger regulatory support for pharma Read More »
By Gil Roth
Published October 26, 2012
What is an IoR? Read More »
By Gil Roth
Published October 26, 2012
Cold Chain is becoming more prevalent in clinical trials. What measures can we take to prevent deviations? Read More »
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