Zdrowie i gospodarka · 27.01.2015
Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled "Current Good Manufacturing Practice Requirements for Combination Products." The guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products, including presenting general considerations for CGMP compliance as well as analysis of hypothetical scenarios.