Fda.gov

U.S. Food and Drug Administration

WebThe 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 …

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URL: https://www.fda.gov/

FDA’s Nutrition Initiatives FDA

WebThe FDA plays a key role within a broader, whole-of-government approach to help reduce the burden of chronic diseases and advance health equity by helping to …

Category:  Health Go Health

FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better …

WebThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of …

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Know Your Treatment Options for COVID-19 FDA

WebFor information specifically about EUAs, direct your health care professional to the FDA’s EUA page, where fact sheets for health care providers are available on …

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What is Digital Health

WebDigital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. These technologies span a wide range of …

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FDA Approved New Drugs in 2022 That Will Improve the Lives of …

WebWe also approved drugs in new settings, such as for new uses and patient populations. Patrizia Cavazzoni, M.D. The 2022 approvals target many different disease …

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COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2 FDA

WebAn example of surveillance testing is a testing plan developed by a State Public Health Department to randomly select and sample 1% of all individuals in a city …

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FDA Authorizes First Over-the-Counter At-Home Test to Detect …

WebThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of …

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Think It Through: Managing the Benefits and Risks of Medicines

WebTo obtain the benefits of riding in a car, you think through the risks. You consider the condition of your car and the road, for instance, before deciding to make that trip to the …

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Products and Medical Procedures FDA

WebDevices used by health care professionals to support patient care, such as hospital beds, infusion pumps, medical device connectors, medical device data systems …

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Cardinal Health Issues Medical Device Recall for Nurse Assist …

WebIn direct response to the Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ …

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FDA approves a new antibacterial drug to treat a serious lung …

WebThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary …

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FDA 101: Dietary Supplements FDA

WebDietary supplements are intended to add to or supplement the diet and are different from conventional food. Generally, to the extent a product is intended to treat, diagnose, cure, …

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BD Recalls Alaris Infusion Pumps Due to Syringe Compatibility Issues

WebThe devices described in this recall are the same devices announced in the Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps - …

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Digital Diagnostics: Over-the-Counter (OTC) and Point-of-Care (POC)

WebThe Department of Health and Human Services (HHS) further defined these data elements through guidance and technical specifications for lab-based tests and non …

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Public meeting: FDA Rare Disease Day 2024

WebFDA will host Rare Disease Day, a virtual public meeting, on March 1, 2024 in global observance of Rare Disease Week. This year’s Rare Disease Day is dedicated to …

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Facts about Dietary Supplements FDA

WebBottom Line: Before buying or using a dietary supplement, read the product label and talk with a doctor, pharmacist, or other health care professional about any …

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Flour Is a Raw Food and Other Safety Facts FDA

WebYou may not realize it, but most flour is a raw food. And it hasn’t been treated to kill any bacteria (germs) it may contain. Cooking and baking is what kills any bacteria …

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Cut Fruit Express Recalls "Fresh Cut Fruit Mix Containing …

WebCut Fruit Express Inc. of Inver Grove Heights, MN, is recalling Caribou Coffee Fruit Mix CHPG 6.5oz, and Cut Fruit Express Brand of 6.5oz, 15oz, 16oz, 32oz …

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Cybersecurity FDA

WebThe U.S. Food and Drug Administration (FDA) is informing laboratory personnel and health care providers about a cybersecurity vulnerability affecting …

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TGD Cuts, LLC Recalls Certain Fresh-Cut Fruit Cup, Clamshell and …

WebTGD Cuts, LLC has initiated a voluntary recall of the specific fresh-cut fruit cup, clamshell and tray products listed below because they contain cantaloupe from TruFresh …

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FDA Releases Annual Summary Report on Antimicrobials Sold or

WebFDA has released the 2022 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, which showed that domestic sales and …

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January 2021 510(K) Clearances FDA

WebCadde,SE DECISION MADE: 05-JAN-21 Istanbul TR 34490 510 (k) STATEMENT DEVICE: Sparrow Therapy System Spark Biomedical, Inc. 510 (k) NO: …

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Interim Policy on Compounding Using Bulk Drug Substances …

WebThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Interim Policy on Compounding Using …

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Roche Amplicor HIV-1 Monitor Test FDA

WebProduct: Roche Amplicor HIV-1 Monitor Test. Applicant: Roche Molecular Systems, Inc., Branchburg, NJ. PMA number: BP950005, Supplement 4. Indication for Use: With …

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NDA 218276 NDA APPROVAL

WebOne Health Plaza, Building 337 East Hanover, New Jersey 07936-1080 . Dear Dr. Shah: Please refer to your new drug application (NDA) dated and received April 5, 2023, and …

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Florida Medical Clinic Owner and Pharmacy Tech Sentenced to …

WebDepartment of Justice U.S. Attorney’s Office Southern District of Florida FOR IMMEDIATE RELEASE Thursday, November 30, 2023. A federal judge sentenced a medical clinic …

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