Date: Tuesday, February 16, 2016
Time: 12:30pm – 1:30pm
Location: Street Level Conference Room
Showing 1 to 2 of 2 items tagged as regulations
Descriptions: "CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act." CBER reports on the availability, recall and approval of such products, like recombinant DNA proteins, blood, vaccine and tissue. As the regulator, CBER provides legal and best practices information for the biologics it oversees, including xenotransplantation. Guidance is provided here for consumers, health professionals and the biologics industry itself. Interested users can sign up for RSS feeds, podcasts and a mailing list.
Keywords: biologics, blood, DNA, hematology, law, medicine, regulations, research, U.S. Government, vaccine
Provider: U.S. Food and Drug Administration
Descriptions: MEDSUN "...is an adverse event reporting program launched in 2002 by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices. Over 350 health care facilities, primarily hospitals, participate in the entire MedSun network." There are MEDSUN sub-networks for various conditions and clinical settings in which medical devices are commonly used: HeartNet, HomeNet, KidNet (neonates), LabNet, SightNet and TissueNet.
Keywords: cardiology, collaborative, consumer health, federal agencies, healthcare professional, heart, laboratory, medical devices, neonatal, ophthalmology, physician, products, radiation, regulations, safety