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PPE Shortages: FDA and Chinese Government Issue New Policies for Masks, Gowns and Gloves

The widely reported shortages of Personal Protective Equipment (PPE), including masks and gowns, across the United States have led to the importation, distribution and use of PPE manufactured overseas. In particular, many...more

FDA's COVID-19 Guidance and Policy Update: March 23, 2020

The U.S. Food and Drug Administration (FDA) has issued several final guidance documents to assist manufacturers developing medical products in response to the coronavirus (COVID-19) pandemic. While some are published as...more

FDA Issues Guidance for Diagnostic Testing Applicable to Coronavirus Disease

The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more

FDA Commissioner Speaks Out on Compliance and Enforcement

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

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