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 »
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 »
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 »
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 »