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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 »
By Gil Roth
Published September 11, 2013
Submit your questions to FDA about the Generic Drug User Fee Amendments 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 »
Are You Gambling With Your Next Inspection?
By Julie Larsen, BioTeknica, Inc.
Published November 9, 2012
10 Key Questions to Assess Inspection Readiness Read More »
Biosimilars, the FDA, and the Supreme Court
By Elizabeth Spar and Tom Wintner, Edwards Wildman Palmer LLP
Published September 6, 2012
Challenges for innovators and biosimilar applicants 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 »
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 »
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