0 words > ! D Question 2 25 pts Skin darkening products have been on the market as over the counter drugs (OTC) for decades. New studies show that the active ingredient X produces some evidence of carcinogenicity in male and female rats and in female mice. Based on the evidence of carcinogenicity in animals, the FDA cannot rule out the potential carcinogenic risk from topically applied ingredient X in humans. The FDA has decided to classify OTC skin darkening drug products containing ingredient X as misbranded, and new drugs within the meaning of section 201(p) of the FDCA. As a result, products that contain ingredient X have been taken off the OTC market. SEpisEP! The court has ruled the FDA's decisions to classify ingredient X as misbranded and a new drug are reasonable. The Court has deferred to the agency's interpretation of ingredient X. SEPisEP Ingredient X is now an OTC drug legally taken off the market. istpiste What are the steps the manufacturer of ingredient X must take to get this drug back on the market? Describe the procedure applying the pertinent sections of the FDCA. Edit View Insert Format Tools Table 12pt v Paragraph B I U A & V TV : Prtson Insert Home End F9 F3 F4 F5 F6 F7 F8 A K 5 8 9 O 4 6 7