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In light of the new efficacy requirement for drug approval, in 1972, FDA established the OTC drug monograph system to handle the high number of drugs already on the market which had not gone through the NDA process to prove safety and effectiveness

In addition to early death, tobacco users are more likely to suffer from debilitating diseases that may prevent them from working, as well as burdening family members and other caregivers

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7 FDA has recommended a vast array of data be developed to meet this standard, including nonclinical, clinical (i.e., human), and long-term studies

If you are considering smoking or vaping, weigh your options before making a decision.