Federal Register Direct final rule: FDA is withdrawing a direct final rule in the 12/4/07 Federal Register that amended 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 to harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. The comment period closed 2/19 and the agency received significant adverse comments. To view this final rule, click here.