Joint virtual press conference with the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration to discuss the lifting of the pause on Johnson & Johnson (Janssen) COVID-19 Vaccine.
Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration has approved three drug treatment for COVID-19 and has authorized others for emergency use during this public health emergency. In addition, many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19.
In this video, Elias Mallis explains FDA’s role in regulating medical devices, review the actual definition and some basics about device classification. He describes the steps to get a new product to market and the different types of premarital regulatory submissions that might be sent. Lastly, identifying three actions that should be taken after watching this video.
This video segment describes how FDA is administering funding to support innovative clinical trial methods and research for the millions of people with rare diseases through their Orphan Products and Natural History Grants Programs. These grants are open to foreign or domestic, public or private, for-profit or nonprofit entities, including patient advocacy groups, academicians, and industry.
The U.S. Food and Drug Administration regulates medical devices, as Jeffrey Shuren, M.D., J.D., Director of FDA's Center for Devices and Radiological Health explains. To help ensure patients with rare diseases have access to needed medical devices, the FDA established the Humanitarian Use Device Program. The program began in 1990 and, since then, FDA has approved 72 devices for rare diseases. Here, agency experts describe three of them.
FDA's Center for Devices and Radiological Health (CDRH) regulates medical imaging devices, including X-ray machines that emit ionizing radiation. While X-ray imaging has led to significant improvements in the diagnosis and treatment of medical conditions in children, it is important that their exposure to radiation be minimized.
This video highlights the main program areas of the FDA Medical Device User Fee Amendments of 2017 (MDUFA IV), designed to advance how FDA fosters innovation and regulates medical devices for patients.
If you’ve used gel nail polish, or have acrylic or gel nails, you’ve probably used ultraviolet (UV) nail curing lamps. These lamps are used to dry or “cure” acrylic or gel nails and gel nail polish, and they feature lamps or LEDs that emit UV radiation. Learn five ways to help reduce your UV exposure from these nail curing lamps—and how to use these products safely.
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