Zdrowie i gospodarka · 27.02.1995
Current Good Manufacturing Practice for Finished Pharmaceuticals; Positron Emission Tomography
The Food and Drug Administration (FDA) is proposing to amend its regulations to permit manufacturers of positron emission tomography (PET) radiopharmaceuticals to apply to the agency for approval of an exception or alternative to the requirements of the current good manufacturing practice (CGMP) regulations. This action is intended to relieve PET manufacturers, nearly all of whom are small entities, from regulations that might result in unsafe handling of PET radiopharmaceuticals, that are inapplicable or inappropriate, or that otherwise do not enhance safety or quality in the manufacture of PET radiopharmaceuticals.