The United States Food and Drug Administration (FDA) recently issued Draft Guidance for Industry entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” (the Draft Guidance). 1/ As FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier explained, part of FDA’s work is “keenly focused on guiding companies on steps needed to

The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was issued in January 2018. The Guidance outlines circumstances when a company should issue a public warning about a voluntary

On December 22, 2018, funding expired for certain agencies within the federal government, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS), and the Consumer Product Safety Commission (CPSC). These agencies will be operating under significantly reduced functions until the shutdown ends, i.e., until Congress passes

The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA).  Together with the release of this Guidance, FDA Commissioner Scott Gottlieb, M.D., released a statement addressing FDA’s goal of expanding use of the mandatory recall authority in

The U.S. Food and Drug Administration (FDA) has issued Draft Guidance on public warning and notification of recalls under 21 C.F.R. Part 7, and has announced steps to release recall information more quickly. The Draft Guidance provides recommendations to industry and FDA staff regarding the use, content, and circumstances for issuing public warnings and public