US FDA

Unapproved New Drugs/Misbranded

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

CGMP/Finished Pharmaceuticals/Adulterated

Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry

This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.

Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.

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.

Over-the-Counter Monograph Drug User Fee annual performance reports to Congress

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers

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

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

Drug Information for Patients and Consumers