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Published May 18, 2015
Will continue to supply Sodium Chloride Injection to alleviate drug shortage Read More »
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 24, 2015
Bangalore oral solids manufacturing facility complied with all FDA requirements Read More »
By Gil Roth
Published February 5, 2014
First-year goals met 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 »
Published March 25, 2013
Similar to Changes Being Effected (CBE). A filing with the FDA to gain approval of a moderate change, i.e., a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as… Read More »
By E. Morrey Atkinson, Ph.D., Cook Pharmica
Published May 4, 2012
. . . But do you know who you are? 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 9, 2014
Hires Quintiles to run PK study Read More »
By Gil Roth
Published October 30, 2013
MannKind tries again with inhaled insulin Read More »


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