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By Gil Roth
Published December 10, 2013
Spokane CMO facility cited by agency Read More »
Labeling on Ferrules and Cap Overseals
By Carol Mooney, West Pharmaceutical Services, Inc.
Published May 6, 2013
What drugmakers need to know about the Revised USP General Chapter <1> Injections Standard 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 »
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 »
By John Avellanet
Published September 7, 2011
Where is the FDA headed? Read More »
Trends in 505(b)(2) Approvals
By Loren Gelber
Published March 3, 2010
The who, what, why, when and how of this hybrid application process 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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