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This means that the manufacturer should submit their data to the FDA to prove that the drug (or biological product) is safe and effective by conducting lab, animal, and human clinical testing for the drugs intended use
Is everyone aligned on treatment goals
Clementi A, Virz GM, Milan Manani S, Battaglia GG, Ronco C, Zanella M
The prevalence of schizophrenia varies by region and country, with East Asia and South Asia having the highest number of cases, with approximately 7.2 million and 4.0 million cases, respectively, in 2016 (Figure 1) (8)
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