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Published March 27, 2015
Eye injection receives FDA approval for the treatment of diabetic retinopathy in patients with diabetic macular edema Read More »
Published March 25, 2015
Triggers $7 million BARDA milestone Read More »
Published March 24, 2015
Bangalore oral solids manufacturing facility complied with all FDA requirements Read More »
Published March 9, 2015
Sandoz Zarxio approved for all indications on Filgrastim label Read More »
Published February 9, 2015
Found to be compliant with cGMP principles and guidelines Read More »
By Gil Roth
Published February 5, 2014
First-year goals met 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 »
FDA’s Friedman on Reliable Manufacturing, From Interphex 2014
By Agnes Shanley, Editor
Published March 20, 2014
At the PDA conference track at Interphex 2014 in New York City, Richard Friedman, Associate Director of FDA’s Office of Manufacturing & Product Quality, discussed what differentiates reliable from unreliable aseptic processes. Read More »


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