SalientCRGT.com 4000 Legato Road • Suite 600 • Fairfax, VA 22033 • 703-891-8200 Background The volume of domestic-produced and imported products under regulation is tremendous and grows rapidly each year. The Food and Drug Administration (FDA) does not have the resources to closely monitor every product. Therefore, the FDA relies on an efficient set of policies, procedures and supporting IT systems to effectively prioritize its efforts. Challenge The FDA performs many functions to safeguard the products under regulation. FDA personnel expend significant effort to evaluate and approve products, conduct facility inspections, collect and analyze product samples, and enforce compliance actions when a violation occurs. Restrictive budgets require the FDA to carefully plan activities f

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