NDA/BLA/MAA

The goal of these plans is to provide a lean, efficient NDA/BLA/MAA with the minimum studies needed for registration and approval in the world markets. The medical, scientific, regulatory and marketing opinions must be weighed and balanced in the plans. 

The requirements for reporting clinical trials to international regulatory authorities are similar in intent but differ in detail. Sponsors approach preparation of NDA/BLA/MAA documentation in a modular format. Each module satisfies a specific documentation need. The modules are generally organized as follows ... 

To be able to prepare annual reports, the sponsor s representative should know how the reports satisfy regulatory authority requirements. The clinical representative should be able to interpret clinical safety and laboratory findings. The ability to understand computer-generated clinical output and the organization and structure of the NDA/BLA/ MAA safety database is important. 

The annual report and NDA/BLA/MAA safety update review and approval procedures must be... 

The knowledge and skill needed to prepare an NDA/BLA/MAA include the ability to... 

In addition, an understanding of electronic NDA/ BLA/MAAs and regulatory authority data presentation requirements are useful. 

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