Vetrano A J
Am J Hosp Pharm. 1980 Apr;37(4):537-40.
The Lannett (United States v. Articles of Drug) and Pharmadyne (Pharmadyne Laboratories, Inc. v. Kennedy) court decisions are explained and their implications regarding premarket approval of drugs are discussed. The Lannett decision has led to confusion over whether FDA premarketing approval is required for products containing drugs recognized as safe and effective. The Lannett decision has no binding legal effect. Premarketing clearance must be obtained by all drug manufacturers, including the producers of generics.
对兰内特公司案（美国诉药品制品案）和法玛迪恩公司案（法玛迪恩实验室公司诉肯尼迪案）的法院判决进行了解释，并讨论了它们对药品上市前批准的影响。兰内特公司案的判决导致了对于含有被认定为安全有效的药品的产品是否需要获得美国食品药品监督管理局（FDA）的上市前批准存在混淆。兰内特公司案的判决没有具有约束力的法律效力。所有药品制造商，包括仿制药生产商，都必须获得上市前批准。
