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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 »
By Gary C. Messplay, J.D.
Published April 30, 2008
Proposed rule to codify long-standing policy stirs debate Read More »
Published December 11, 2007
John Goodacre has been named executive vice president and general counsel of Quintiles Transnational Corp. Previously senior vice president, Global Risk Management and Quality Assurance, Mr. Goodacre joined Quintiles in 1998 as vice president, Europe… Read More »
Published May 16, 2007
Dennis Gillings, CBE, chairman and chief executive officer of Quintiles Transnational Corp., dedicated a new facility in Overland Park, KS, with Secretary David Kerr of the Kansas Department of Commerce. The 236,000-sq.-ft. building will house Qu… Read More »
By Anna Shagako, Clinical Operations Head
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