ALERT UPDATE: FDA response to the Diamond Shruumz-Brand investigation has ended and transitioned to post-incident actions and activities. All Diamond Shruumz-brand products have been recalled and should no longer be available for sale. https://lnkd.in/gGjV_yik
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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The FDA has issued a Letter to Health Care Providers to alert health care providers and facilities about safety concerns with the use of Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, and a supply concern for EVH devices. This letter addresses the following: • Information on affected products • Recommendations for health care providers and facilities • Actions that the FDA is taking to address the issue • Instructions for reporting problems with a device Find out more: https://lnkd.in/eSkTDpsW
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🔊 Learn about FDA’s recent oncology treatment approval of Keytruda (pembrolizumab) in the latest FDA DISCO podcast: https://lnkd.in/eUngzQXe
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#Biosimilars provide a significant opportunity to expand patient access to essential medicines without sacrificing product quality. Data shows that when comparing a biosimilar to its FDA-approved reference product, there are no clinically meaningful differences in safety, purity, or potency. Like all biologics, biosimilars are tested in accordance with the Current Good Manufacturing Practice regulations enforced by the FDA. For more information about the quality, safety, and effectiveness of biosimilars, view the new educational resource from FDA and US Pharmacopeia: https://lnkd.in/dPRTAbBR  #GlobalBiosimilarWeekÂ
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Today, FDA released guidance with revisions to the Food Safety Modernization Act #FSMA Voluntary Qualified Importer Program #VQIP. The implementation of this revised inspection approach is strategically designed to optimize program efficiency by leveraging other oversight activities. Learn more about these updates and more about the advantages of participating in VQIP. https://lnkd.in/ezejn8Jd
FDA Updates VQIP Guidance
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FDA's Oncology Center of Excellence and the American Association for Cancer Research are jointly holding a workshop to discuss dihydropyrimidine dehydrogenase (DPD) deficiency testing before chemotherapy with fluoropyrimidines—the current landscape and future directions. Hope to see many of you there on January 16, 2025 – register for in-person or virtual attendance. https://lnkd.in/eNNX4NFS
2025 FDA-AACR Workshop: DPD Deficiency and Weighing Potential Harms
https://www.aacr.org
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Today we approved an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. https://lnkd.in/er5tacke Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency.
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Today we approved an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency. https://lnkd.in/er5tacke
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Want to hear patient and caregiver perspectives on #genetherapy clinical trials for early-stage and pre-symptomatic diseases? Join FDA CBER for our next virtual listening meeting on December 4th at 11:00 a.m. EST. Learn more and register at https://bit.ly/4h3DB0p
Meeting 2: Perspectives on Early Gene Therapy Trials
fda.gov