Project Feasibility Research and Evaluation for Generic Drug

OBJECTIVE To provide guidance and assistance for Chinese enterprise planning to apply for ANDA approval from the FDA. Introduce how to get the target product and how to investigate and evaluate, then finally make the strategy. METHODS The methodology mainly used was exemplification. RESULTS Obtained the way and methods of collection and evaluation of drug information in the U.S., clarified the factors of generating development and registration strategies. CONCLUSION Drug information in the U.S. is transparent and public relatively, and available from public sources. The project evaluation can't be absolutely correct, so enterprises can set up their acceptable standards according to their own requirements.