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By Gil Roth
Published December 9, 2013
Helsinn, Eisai file for netupitant, palonosetron combo Read More »
By Gil Roth
Published November 21, 2013
Type C meeting reviews cGMP manufacturing space Read More »
By Ronald A. Rader, Biotechnology Information Institute
Published September 5, 2013
Citizen petition requests biopharmaceutical names and information be disclosed by FDA 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 October 8, 2012
Reviewed systems, processes and procedures, with no Form 483 observations Read More »
Published April 25, 2012
FDA to accept some studies, require reanalysis for others Read More »
Published February 13, 2012
No 483 observations issued Read More »
Published August 12, 2011
To manufacture a solid dose product for a client 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 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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