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Published August 5, 2014
Ireland facility gains pre-approval Read More »
Published April 30, 2014
Analytical and stability testing, and CTM services deemed compliant 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 »
Published February 19, 2014
13 prequalified companies will participate in program to enhance security of imported drugs Read More »
Published October 22, 2013
Audits demonstrate custom manufacturing capabilities Read More »
FDA’s Quality Agreement Guidance Vs. EMA’s cGMP Regulations
By John Avellanet, Cerulean Associates LLC
Published October 9, 2013
Can you comply with both? Read More »
By Gil Roth
Published September 12, 2013
Ganetespib to help treat adenocarcinoma Read More »
By Gil Roth
Published September 11, 2013
Submit your questions to FDA about the Generic Drug User Fee Amendments Read More »
By E. Morrey Atkinson, Ph.D., Cook Pharmica
Published May 4, 2012
. . . But do you know who you are? Read More »
Published September 12, 2012
Four newly approved sites expand presence in U.S. market Read More »
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