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Published February 17, 2015
Sterile fill production facility found in accordance with regulatory requirements Read More »
Published November 7, 2014
To develop PRO measure for anti-bacterial drug development trials for pneumonia Read More »
Published October 14, 2014
Will undertake a regulatory document inventory and evaluation of Provectus’ information management system Read More »
Published June 10, 2014
One Spray per Device, Without the Need for Priming, Provides Greater Ease of Use 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 »
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 »
Packaging Serialization Update
By Stephen Barlas, Contributing Writer
Published March 7, 2012
FDA reviews obsolete 2004 barcode rule Read More »
Published February 27, 2012
An FDA-approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the RLD in its ANDA. By designating a single RLD as the standard… Read More »
Published February 27, 2012
Application submitted for an already approved NDA for any changes in packaging, labeling, dosages, ingredients or new indications.… Read More »


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