Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu
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.
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OMUFA Performance Reports
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
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers -
AI Airlock, CERSIs and a new global AI network for health regulators
Med Tech Regs blog, June 2025: A focus on Software and AI.
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mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination -
Research: Review of risk minimisation for disabling and potentially long-lasting/irreversible side effects associated with fluoroquinolone antibiotics
Public Assessment Report on the review of risk minimisation for fluoroquinolone antibiotics.
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If you take a GLP-1 medicine and have been hospitalised by acute pancreatitis, the Yellow Card Biobank wants to hear from you
GLP-1 medicines are licensed for Type 2 diabetes and weight management, and include the branded products Ozempic, Mounjaro and Wegovy
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Kilwins Quality Confections, LLC. Issues Allergy Alert on Undeclared Pecans in Mocha Truffles
Kilwins Quality Confections, LLC., of Petoskey, Michigan, is voluntarily recalling Mocha Truffles because they may contain undeclared pecans. -
Information for Consumers and Patients | Drugs
Drug Information for Patients and Consumers -
Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation
Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact. -
For Healthcare Professionals | FDA’s Examples of Drugs that Interact with CYP Enzymes and Transporter Systems
FDA’s Examples of Interacting Drugs and Other Substances Involving CYP Metabolic- and Transporter System-Based Pathways for Healthcare Professionals -
Search for Regulatory References | Drugs
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more