GMP Training - FDA withdraws GMP Changes - Apr 14, 2008

The FDA withdrew a direct final rule that was published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations.

FDA is withdrawing the direct final rule because the agency received significant adverse comments. In their announcement, FDA said that it will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December 4, 2007, as a companion to the direct final rule (72 FR 68113).

Stay tuned.

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