The Regulatory Process
The Regulatory Process provides a summary of the regulatory bodies involved in approving both small molecule drugs and biologics. Understand the application process involved in moving a drug candidate from preclinical studies in animals to human clinical studies, to final approval allowing for marketing and sale of a drug product. Learn the ways a drug candidate approval can be expedited so life saving medicines can get to patients faster. Familiarize yourself with the US Prescription Drug User Fee Act (PDUFA) which governs it all. The Regulatory Process class gives an overview of all regulatory considerations a drug manufacturer should take into account as it seeks to prove their drug is safe and effective.
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