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By Gil Roth
Published January 8, 2014
No observations at Manchester, NH site following GMP/PAI visit Read More »
By Kristin Brooks
Published December 17, 2013
IA site GMP compliant, with no Form 483 observations Read More »
Published March 22, 2013
New program combines clinical trial and bioanalytical activities Read More »
Published February 1, 2013
PAI triggered by a top pharma company’s NDA filing Read More »
Published January 7, 2013
Successful inspection reviewed procedures and processes for oral solids manufacture Read More »
Published January 24, 2012
U.S. patients will return to full Fabrazyme dosing in March 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 Gary C. Messplay, J.D.
Published April 30, 2008
Proposed rule to codify long-standing policy stirs debate Read More »
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