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CDER, which is responsible for ensuring the safety and effectiveness of both over-the-counter and prescription drugs, and CBER, which is responsible for regulating biological and related products like vaccines, blood, tissues, and cellular and gene therapies, both operate through the FDA
The New England Journal of Medicine, 393(11), 10771087
Maresca P et al
doi: 10.1038/s41374-020-00508-y 67 YuMWangDZhongDXieWLuoJ
Conclusion HorseFil is built for the long game, and thats not a drawback, its the point
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