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FDA Inspection Trends
By Michael Klapal, Drug Specialist - U.S. FDA
Published October 1, 2014
Topics: • Quality Agreements • Inspection Trends • Field Alert Reporting Trends… Read More »
Published July 22, 2014
Will produce NME for U.S. market Read More »
Published April 30, 2014
Analytical and stability testing, and CTM services deemed compliant Read More »
By Gil Roth
Published December 10, 2013
Spokane CMO facility cited by agency 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 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 »
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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