Implementation of users

The format and content of the documents in an NDA and the administrative actions associated with an NDA continue to evolve. In the last 10 years, the NDA process has been affected by increasing globalization, serious incidences of fraud and graft, the AIDS epidemic, increased ease and speed of electronic data transfer, and greater accountability within the executive branch of the government. One example of the result of these forces was the implementation of user fees and the significant shortening of the review times by the FDA. 

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