The U.S. Food and Drug Administration (FDA) holds primary responsibility for approving and regulating various human and animal prescription drugs, medical and tobacco products and the nation’s food supply.
To conduct preclinical testing of locally-acting topical dermal and ophthalmic drug product formulations
TECLens, a medical device manufacturer and SERVImed Industrial Spa, an ophthalmic medical devices manufacturer and distributor today announced their partnership aimed at development and FDA approval of a new combination product to treat keratoconus.
TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), has been named a technology partner in two coordinating centers of the FDA's Sentinel System, a national program that uses electronic health care data to monitor the safety of FDA-regulated drugs and other medical products.
ProTom International Holding Corporation ("ProTom"), a market-leading proton therapy technology manufacturer, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its Radiance 330 proton therapy system installed at Massachusetts General Hospital ("MGH") in Boston, Massachusetts.
Laser Associated Sciences' Non-Invasive Device Disrupting the Industry
Experts Will Present MDX Platform at ISPOR in Denmark in Early November
Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas, on measuring the progress being made through implementing the FDA Food Safety Modernization Act
The opioid crisis has become such a public health crisis that there is now a Prescription Opioid and Heroin Epidemic Awareness Week to focus on the dangers of opioid addiction as well as treatment options treatment – which includes access to Naloxone.
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As more people become ill from using vaping products, government authorities are beginning to take a hard look at e-cigarettes.
AI-based software enables automated enhanced visualization of CT images of the lungs, heart, and aorta
Annexon plans to advance the clinical development of ANX005 for the treatment of GBS
The Prescription Drug Pricing Reduction Act (PDPRA) is expected to work its way through Congress this fall.
FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway
The Trump administration’s move to ban certain flavors of e-cigarettes and vaping devices either goes too far or doesn’t go far enough, according to those on opposite sides of the debate.
First RECELL System clinical trial in the U.S. focused on acute soft tissue injuries, defects, and reconstruction; study expected to commence within next 6 months
Gottlieb joins as Aetion advances real-world evidence for making drug development and commercialization more efficient