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Last Updated Thursday, October 23 2014
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Search Results for 'CBE'

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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 »
Published July 29, 2010
Quintiles is relocating its European headquarters to Green Park, Reading, England, which is located 30 minutes from Heathrow Airport. Read More »
By Gary C. Messplay, J.D.
Published April 30, 2008
Proposed rule to codify long-standing policy stirs debate Read More »
Published August 15, 2007
Michael Troullis has been named chief financial officer, Quintiles Transnational Corp., effective immediately. Mr. Troullis had been acting chief financial officer for the past year. He will report to Dennis Gillings, CBE, chairman and chief executiv… Read More »
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