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In the United States , biologics are regulated by the FDA's Center for Biologics Evaluation and Research (CBER) whereas drugs are regulated by the Center for Drug Evaluation and Research . Approval may require several years of clinical trials , including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks. The manufacture process must satisfy the FDA's "Good Manufacturing Practices", which are typically manufactured in a clean room environment with strict limits on the amount of airborne particles.

Farmacos antiinflamatorios esteroideos aines

farmacos antiinflamatorios esteroideos aines

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