Today, we approved a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma. Synovial sarcoma is a rare form of cancer in which malignant cells develop and form a tumor in soft tissues of the body. https://lnkd.in/e9_Mh_av
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/
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
-
Primary
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
-
#DYK Federal law authorizes the FDA to charge a fee for medical device product review and establishment registration? Find out more about the #MedicalDevice user fees, annual establishment registration fees, and the small business program for FY2025. https://lnkd.in/ebC6Ke-E
-
-
Save the date! On September 25, 2024, FDA will hold a public meeting on the "Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food." This is part of our larger enhanced approach for food chemical safety. https://lnkd.in/eXvpcr4J
-
-
Did you know? Doctors, PAs and NPs w/ current DEA registration for prescribing controlled substances can also prescribe buprenorphine for OUD. Learn more: https://lnkd.in/eH79kTcC #PrescribeWithConfidence #OUD
-
Reprocessing and reusing single-use devices (SUDs) can save costs for health care facilities and reduce medical waste. Manufacturers may label a device for single use when it is not designed to be reused or if the manufacturer chooses not to submit data to support reuse. However, the single-use label does not mean the device cannot be reprocessed. When a commercial reprocessor or health care facility intends to reprocess a SUD, they are held to the same regulatory requirements as the original manufacturer of the device. Here’s what health care facilities should know about reprocessing SUDs: https://lnkd.in/eiUsYFYJ
-
-
Be part of the FDA’s Human Foods Program #HFP mission-driven team and help protect the nation’s food supply. We are excited to announce several HFP executive career opportunities. All positions are posted from August 1, 2024 – August 30, 2024. https://lnkd.in/eRtwmFPw FDA has an ongoing need for qualified individuals with backgrounds in biology, microbiology, chemistry, toxicology and other health-related sciences, data science, food safety, nutrition, health policy, health communications, and regulatory counsel as well as other professional and administrative fields. #hiring #jobopenings #foodscientists #foodsafety #foodchemicalsafety #nutrition #healthpolicy
-
-
FDA announces the Advancing Real-World Evidence (RWE) Program submission deadline for the fourth submission cycle as September 30, 2024: https://lnkd.in/gQwtSr72 For selected product sponsors, the Advancing RWE Program provides the opportunity to meet with FDA staff in the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Oncology Center of Excellence—before protocol development or study initiation—to discuss the use of RWE in medical product development.
-
Today, we issued a Letter to Health Care Providers to raise awareness about the safe use of Mega 2000 and Mega Soft Patient Return Electrodes by Megadyne Medical Products, Inc. Since June 2023, Megadyne has initiated four voluntary recalls due to reports of burn injuries in pediatric and adult patients and health care providers. Find out more: https://lnkd.in/dMd3ESPm
-
-
📣 ATTN HCPs: Do your patients have questions about generic drugs? FDA has patient education materials for you to share on social media or download and print to share in your office: https://lnkd.in/gZ-KSRvi
-
📣 Don't miss out! Join FDA for a public meeting to discuss approaches to developing drugs to treat the negative symptoms of schizophrenia & disseminate important regulatory considerations for programs designed to evaluate these drugs. Register today➡ https://lnkd.in/gmykeyYE
-