FDA granted marketing authorization for a COVID-19/flu test for use without a prescription. This is for use by individuals experiencing respiratory symptoms & uses a nasal swab sample to deliver at-home results for COVID-19 and flu. This is the first OTC test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration. https://lnkd.in/ecwCJ72g
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
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http://www.fda.gov/
External link for FDA
- 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
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Primary
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10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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We’re kicking off National Health Care Supply Chain Week, and this year’s theme is “Excellence in Every Link.” Our Office of Supply Chain Resilience (OSCR) strengthens public health supply chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to prevent shortages of #MedicalDevices. Learn more about OSCR: https://bit.ly/3BlaWnh #SCWeek
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FDA Office of Women’s Health (OWH) released its updated Women’s Health Research Roadmap. The Roadmap outlines priority areas in which new or further research is needed and serves as a catalyst for research collaborations both internal and external to the FDA. It will be used by OWH as a tool to promote women’s health research, advance strategic and diverse research investments, maximize research impact, improve collaboration within and external to FDA, and support the translation of research advancements to improve health outcomes. Download the updated roadmap here: https://lnkd.in/e7GGGRhM #WomensHealth #Research
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Questions about the use and safety of cannabis products? Join our webinar which will provide insights into the landscape of the cannabis marketplace and some general information on how products are manufactured and regulated.
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FDA approved a treatment for resectable non-small cell lung cancer without EGFR mutations or ALK rearrangements: https://lnkd.in/g_JfxqT9
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Over-the-counter skin lightening products that include ingredients such as hydroquinone and mercury can cause skin rashes, facial swelling, and discoloration of skin. Most consumers report exploring or using products to address various skin issues, such as scarring, melasma, sun damage, psoriasis, and “to even” their skin tone. The FDA is taking a comprehensive approach to protect consumers from the risks posed by skin lightening products, including education, outreach, and public awareness activities on the use of and potential risks from skin lightening products containing hydroquinone or mercury. To learn more about FDA’s findings, read the publication below and visit: https://lnkd.in/exKj8pU9 This research was conducted by Richardae Araojo, Lea Ann Browning-McNee, Linda Katz, Prashiela Manga, Theresa Michele, Christine Lee-Flemming, PhD, PharmD, Yvonne Santiago, Julie Hsieh, and Tony Welch.
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Health literacy is defined as the degree to which people have the ability to find, understand, and use information to help them make health-related decisions. #HealthLiteracy plays an important role in protecting public health and promoting health equity, so that everyone has an opportunity to be as healthy as possible. To support these efforts, we strive to provide clear, easy-to-understand communications. In support of Health Literacy Month, we encourage you to learn more about plain language principles: https://bit.ly/4egHb5E #HealthLiteracyMonth
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Join FDA & the Center for Research on Complex Generics on Nov. 6-7 for the "Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products" event! Stay updated on the latest regulatory requirements and industry trends: https://lnkd.in/ed8y237A Network with experts and peers to discuss the latest nitrosamine research, recommendations, and best practices for ensuring drug safety, efficacy, and quality. Register now! ➡️ https://lnkd.in/ehKKrdwU
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FDA continues its work on Highly Pathogenic Avian Influenza (HPAI). This week we invited state partners to participate in a new study to help us understand the prevalence of H5N1 in bulk raw cow’s milk received by dairy processing facilities in the U.S. https://lnkd.in/g4cN7BHb