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This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with…

Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry

mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

CHINCOTEAGUE, Virginia — Cuando Azania Lane-Majestic llegó a la playa con su familia, su entusiasmo inicial se convirtió en preocupación. No había salvavidas a la…

CHINCOTEAGUE, Va. — When Azania Lane-Majestic arrived at the beach with her family, her initial excitement gave way to concern. No lifeguards could be seen…

In a top-rated nursing home in Alexandria, Virginia, the Rev. Donald Goodness is cared for by nurses and aides from various parts of Africa. One…

Shang Hao Jia, Inc. of South El Monte, CA is recalling 50 case of Danshi brand Spicy Shredded Tofu, because it may contains undeclared sesame.

Mellace Family Brands California, Inc. of Warren, OH is recalling Wegmans Semi – Sweet Chocolate Nonpareils, because they contain undeclared milk allergen. People who have an allergy or severe sensitivity to…

Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

Kilwins Quality Confections, LLC., of Petoskey, Michigan, is voluntarily recalling Mocha Truffles because they may contain undeclared pecans.