FDA approves new drug for multiple sclerosis
People who suffer from multiple sclerosis (MS) have a new hope of slowing the progression of their disease with the U.S. Food and Drug Administation’s (FDA) approval of a new drug.
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FDA studying ways to improve medical device safety
Silicone breast implants, metal rods to stabilize broken bones, heart valves made from the tissues of pigs and cows—modern medical technology is continually developing devices to implant in human bodies to improve health, quality of life, or appearance.
Medical device makers likely to benefit from ‘similar product’ expedited approval process in 2019
Keeping pace with technology that seems to develop at the speed of light and getting medical treatments to the people who most need them as quickly as possible while still maintaining top standards and keeping patients safe is tricky for the U.S. Food and Drug Administration, but that is its job.
Seminar scheduled for learning how to handle FDA recalls
No company wants its product recalled by the U.S. Food and Drug Administration, but it can happen despite the most careful product planning.
Administration proposes Medicare patients get coverage for innovative devices
The current administration’s proposed budget for 2020 includes allowing Medicare patients to benefit from more and longer access to “breakthrough” medical devices, and the industry could not be happier.
FDA regulations easier for devices than drugs
The U.S. Food and Drug Administration is the agency that ultimately decides upon the safety of medical applications, both pharmaceuticals and devices, and approves their use by providers to the public.
Natural Cycles contraception app gets final FDA clearance
This month the U.S. Food and Drug Administration took the final steps in clearing the first family-planning app approved for use in the U.S.
21st Century Cures Act: Interoperability, information blocking and the ONC Health IT Certification Program
While today's technology offers us a world of information that previous generations never even dreamed of being so accessible, important medical and health records remain time-consuming and difficult to obtain.