STEPS IN NEW DRUG

STEP 1 From the Drug Company - Scientists discover a new compound with the potential to become a meaningful medicine - Drug companies test drugs on animals to learn more about its safety and how it works. STEP 2 IND submission - Drug company submits an investigational New Drug (IND) application to the FDA. STEP 3 IND review: FDA works to ensure proposed Clinical trials: - Do not place participants at extreme risk or harm - Provide informed consent and STEP 4 NDA SUBMISSION: - Company submits a new drug application, including the results of all trials, as well as manufacturing information, to the FDA STEP 5 NDA ACCEPTANCE and review: 60 days later, FDA decides if it will accept the NDA After 10 months, review the application for drugs that offer only minor improvements. After 6 months for drugs that offer major advances in treatment.