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In the USA current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. A sponsor will need to ship the investigational drug to clinical investigators in many states. To do this the sponsor must seek an exemption from the legal requirement of having to hold the approved marketing application. Through what method does the sponsor technically obtain this exemption from the FDA?
Approximately how much is the fee for to submit an new drug application to the US FDA that contains data from clinical trials?
In 1992 a law was passed in the USA to allow the FDA to collect fees from sponsors to fund the new drug review and approval process. What is this law better known as?
