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Published July 8, 2014
Inspection covered quality system and lab facilities in Torrance, CA Read More »
Published April 30, 2014
Analytical and stability testing, and CTM services deemed compliant Read More »
Published April 24, 2014
Employs Novozymes' VELTIS technology for optimized dosing Read More »
FDA Aseptic Inspections Will Focus on Process, FDA’s Friedman Says
Published March 27, 2014
At a PDA conference track at Interphex 2014, FDA’s Richard Friedman, Associate DirectorAssociate Director of FDA’s Office of Manufacturing and Product Quality at the Center for Drug Evaluation and Research’s Office of Compliance, discussed changes in the way FDA inspectors will review aseptic facilities. The emphasis now, he says, will be on day to day process operations and control. Read More »
By Gil Roth
Published February 5, 2014
First-year goals met Read More »
By Gil Roth
Published May 29, 2013
Stresses use of Quality Agreements between clients, CMOs Read More »
By E. Morrey Atkinson, Ph.D., Cook Pharmica
Published May 4, 2012
. . . But do you know who you are? Read More »
Published February 27, 2012
See Food and Drug Administration.… Read More »
Increased FDA Scrutiny of Purchasing / Supplier Controls
By Braulio Ortiz, Michael Neaves
Published October 8, 2010
Multiple perspectives on shifting regulatory burdens Read More »
By Gil Roth
Published January 8, 2014
Natpara action date October 2014 for hypoparathyroidism indication Read More »
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