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By Gil Roth
Published December 20, 2013
BMS, Pfizer seek new indications against DVT, PE Read More »
By Gil Roth
Published October 30, 2013
MannKind tries again with inhaled insulin Read More »
Critical Design Strategies for Extractables and Leachables Control
By Thomas Feinberg, Catalent Pharma Solutions
Published April 3, 2013
Methods for avoiding contamination Read More »
Published February 4, 2013
Will be used for biomarker qualification process 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FDA revises draft guidance document to address industry comments Read More »
By Gil Roth
Published January 17, 2012
Elder leaves agency after more than two decades Read More »
Published June 15, 2011
Dr. Reddy’s chemical manufacturing facility in Cuernavaca, Mexico has received a four-item Warning Letter from the FDA. 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 »
Published June 28, 2007
SGS India Ltd.'s Chennai facility has passed an FDA inspection conducted in February 2007. It was both a pre-approval and a GMP inspection. The facility is classified as "acceptable." This was the first FDA inspection of the SGS QC testing… Read More »

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