FDA

FDA

Government Administration

Silver Spring, MD 809,940 followers

About us

The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

Website
http://www.fda.gov/
Industry
Government Administration
Company size
10,001+ employees
Headquarters
Silver Spring, MD
Type
Government Agency
Specialties
Food, Drugs, Medical Devices, Vaccines Blood and Biologics, Animal and Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products, Regulatory Research, and Toxicological Regulatory Research

Locations

Employees at FDA

Updates

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    FDA approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. Merilog is the third insulin biosimilar product approved by the FDA and joins the two long-acting insulin biosimilar products approved in 2021 by the FDA. Approval of biosimilar products can increase patient access to safe and effective treatment options. Like Novolog, Merilog should be administered within five to ten minutes prior to the start of a meal. Merilog is administered subcutaneously (under the skin) by injection into the stomach, buttocks, thighs or upper arms. Dosing of Merilog should be individualized and adjusted based on the patient’s needs. Merilog may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions and hypokalemia (low potassium in blood). Other common side effects may include injection site reactions, itching, rash, lipodystrophy (skin thickening or pitting at the injection site), weight gain and swelling of hands and feet. Learn more in the FDA-approved prescribing information below and at: https://lnkd.in/ex3rSfQ3

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    FDA qualifies a drug development tool to facilitate clinical trial research on alcohol use disorder: https://lnkd.in/d6RrpuBx This tool provides a new endpoint option for researchers and drug developers alongside abstinence and no heavy drinking days. With this qualification, investigators can now determine if their proposed treatment works as they expect based on whether it reduced risk drinking levels by two levels in clinical trials.

    • A graphic featuring a person looking at a smartphone, with the word "ANNOUNCEMENT" prominently displayed in the center. FDA logo in bottom right corner. The background includes abstract geometric shapes and a blue color scheme.
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    The Louisiana Department of Public Health has issued a recall for certain oysters harvested from Louisiana Area 3 from 1/10/2025 - 2/4/2025. The oysters were shipped to distributors and retailers in AL, FL, LA, MD, MS, NC, and TX and may have been distributed to other states. https://lnkd.in/edA4xq6f The FDA is advising restaurants and food retailers not to serve or sell and to dispose of, and consumers not to eat, these oysters following the instruction provided below because they may be contaminated with norovirus.

    Safety Alert

    Safety Alert

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    OUTBREAK: Salmonella investigation in Sweet Cream-Brand Mini Pastries with a best buy date of June 17 – November 15, 2025. Recalled mini pastries were distributed in FL, NJ, NY, and PA to food service locations such as hotel cafes, bakeries, institutions, and restaurants. The firm has directly notified customers who received the recalled product, and the recalled product should no longer be available for sale. This advisory will be updated as needed. https://lnkd.in/eEuxVdgb

    Outbreak Investigation

    Outbreak Investigation

    fda.gov

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    FDA is alerting patients who use diabetes devices as well as their caregivers, of a safety concern regarding alerts from continuous glucose monitors (CGMs) and other diabetes devices not being delivered or not being heard on their compatible smartphones. In some cases, missing these alerts may have contributed to serious harm including severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, and death. Find out more: https://lnkd.in/e_BcR83u

    • Person looking at a smartphone. Text reads Regularly check your diabetes-related smartphone device alert settings.
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    FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. This is the first drug to be approved in this new class of pain management medicines. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. Additionally, patients should avoid food or drink containing grapefruit when taking Journavx. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Reduce dosage in patients with moderate hepatic impairment as use may increase the risk of adverse reactions. The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Learn more in the FDA-approved prescribing information below and at: https://lnkd.in/dUUs3fxB.

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