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By Kristin Brooks
Published December 17, 2013
IA site GMP compliant, with no Form 483 observations Read More »
By Gil Roth
Published December 2, 2013
AcelRx pain management system to be reviewed Read More »
By Gil Roth
Published November 21, 2013
Type C meeting reviews cGMP manufacturing space Read More »
Published March 22, 2013
New program combines clinical trial and bioanalytical activities Read More »
Published January 7, 2013
Successful inspection reviewed procedures and processes for oral solids manufacture Read More »
By Gil Roth
Published July 27, 2011
Synthesis sites in France, Bahamas pass muster Read More »
By Heather D. Bau00f1uelos
Published July 13, 2011
A busy year for the agency Read More »
Published March 3, 2011
Lyophilization Services of New England, Inc. (LSNE) has recently completed a comprehensive FDA audit of its medical device manufacturing facility in Manchester, NH. Read More »
By Stephen Barlas
Published February 15, 2011
Confusion, anxiety reign as Agency talks tagging Read More »
By Gary C. Messplay, J.D.
Published April 30, 2008
Proposed rule to codify long-standing policy stirs debate Read More »
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