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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 »
Published October 21, 2013
Goedheijt and Douwstra to head operations and production 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 Gary C. Messplay, J.D., Allison L. Reschovsky, J.D., and Adele M. Kaplan Gilpin, J.D., Ph.D., Hunton & Williams LLP
Published May 30, 2012
A new era of clinical trial transparency enforcement Read More »
By Kyle Sampson, J.D., and Brian J. Wesoloski, J.D., Hunton & Williams LLP
Published March 7, 2012
New guidance seeks to clear up manufacturer communications 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 »
By John Avellanet
Published September 7, 2011
Where is the FDA headed? Read More »
Responding to a WARNING LETTER
By Shamik Pandit
Published April 30, 2008
Part 2 of 2 on what to do when the FDA sends you a letter Read More »
By Gil Roth
Published December 9, 2013
Helsinn, Eisai file for netupitant, palonosetron combo Read More »
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