Chemistry, Manufacturing, and Control Requirements of the NDA and AND A

With the enactment of the FDA Modernization Act of 1997 (FDAMA) and multiple reauthorizations of the Prescription Drug User Fee Act of 1992 (PDUFA), the drug approval process by the FDA is expected to be streamlined further. The agency has aggressively generated guidance documents to implement the provisions of the statute, and it continues the process to this date. Therefore it is up to the drug sponsor to prepare drug submissions that are complete and in a format that will facilitate the review and lead to a rapid approval.