http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2007-12-04/ Daily Publications of Meetings and Rules Changes for the Federal Government Wed, Oct 15 2008 11:00:00 GMT Wed, Oct 15 2008 11:00:00 GMT info@thefederalregister.com http://thefederalregister.com/d.p/2007-12-04-E7-23294 ]]> http://thefederalregister.com/d.p/2007-12-04-E7-23294 Tue, Dec 4 2007 11:00:00 GMT http://thefederalregister.com/d.p/2007-12-04-E7-23292 ]]> http://thefederalregister.com/d.p/2007-12-04-E7-23292 Tue, Dec 4 2007 11:00:00 GMT http://thefederalregister.com/d.p/2007-12-04-E7-23271 withdrawal of a proposed rule published in the Federal Register of May 3, 1996 (61 FR 20103) (the May 1996 proposed rule). The May 1996 proposed rule would have amended certain requirements of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These proposed changes would have clarified certain manufacturing, quality control, and documentation requirements and would have updated the requirements for process and methods validation. In light of more recent scientific and technical advances and evolving quality systems and risk management concepts, FDA concludes that, at this time, it is appropriate to withdraw the May 1996 proposed rule and newly evaluate the issues raised in that proposal. ]]> http://thefederalregister.com/d.p/2007-12-04-E7-23271 Tue, Dec 4 2007 11:00:00 GMT http://thefederalregister.com/d.p/2007-12-04-E7-23473 ]]> http://thefederalregister.com/d.p/2007-12-04-E7-23473 Tue, Dec 4 2007 11:00:00 GMT