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By Kristin Brooks
Published March 28, 2014
Erin Bosman of Morrison & Foerster explores potential repercussions Read More »
By Mario C. Filion, Director
Published March 25, 2013
See Changes Being Effected.… 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 »
Published March 25, 2013
A filing with FDA by holder of NDA, ANDA or BLA to notify the agency of minor changes in manufacturing processes or control. See also CBE 30 and Prior Approval Supplement.… Read More »
Published March 25, 2013
A filing with the FDA to gain approval of a major change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of… Read More »
By Gil Roth
Published June 18, 2012
HQ set for Shanghai, JV to add lab testing services Read More »
By Gary C. Messplay, J.D.
Published April 30, 2008
Proposed rule to codify long-standing policy stirs debate Read More »
Published February 13, 2006
Quintiles Transnational Corp. will build a new structure in Overland Park, KS to house the Clinical Development Services (CDS) and Clinical Pharmacology units now in Kansas City and the Phase I Research unit located in Lenexa, KS. The new facility wi… Read More »
By Anna Shagako, Clinical Operations Head
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