Zdrowie i gospodarka · 29/07/1996
Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to September 30, 1996, the comment period for the proposed rule that would revise the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The proposed rule was published in the Federal Register of May 3, 1996 (61 FR 20104). The proposal would clarify certain manufacturing, quality control, and documentation requirements and would ensure that the regulations more accurately encompass CGMP. The agency is taking this action based on a request for an extension of the comment period.