United States federal regulator at Silver Spring in Maryland, an agency of the Department of Health and Human Services, responsible for protecting public health through the regulation of medicines, biologics, medical devices, food, cosmetics, tobacco and radiation emitting products. Reviews and approves new drug and biologics applications and generic and biosimilar filings through its Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, inspects manufacturing sites for good manufacturing practice worldwide, oversees clinical trials and labelling, runs post market safety surveillance and recalls and publishes guidance and the Orange and Purple books.
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