US Food and Drug Administration [FDA] announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
Showing posts with label US FDA. Show all posts
Showing posts with label US FDA. Show all posts
Tuesday, April 9, 2019
Sunday, February 18, 2018
FDA approves first blood test to evaluate concussions in adults
Medical providers will have a new tool to diagnose concussions since as the U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly called a concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program. The new quick testing option will help reduce the need for CT scans, radiation exposure, for patients.
Thursday, April 23, 2015
US FDA: Designation for CRS-207 in Mesothelioma Treatment
Today's post is shared from finance.yahoo.com/news
Aduro Biotech, Inc. today announced that the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CRS-207, a novel immuno-oncology product candidate, for the treatment of mesothelioma. This designation potentially allows Aduro seven years of limited marketing exclusivity in the United States if it is the first to obtain FDA marketing approval for mesothelioma, and qualifies the company for grant funding to offset the cost of clinical testing as well as tax credits for certain research and a waiver of the Biologics License Application user fee. The FDA previously granted orphan designation to CRS-207 and GVAX Pancreas for the treatment of pancreatic cancer.
“This is an important step for Aduro as we continue to develop CRS-207 for this very difficult to treat cancer,” said Dirk Brockstedt, Ph.D., senior vice president of research and development at Aduro. “We believe the combination of CRS-207 together with chemotherapy may offer the promise of a potential new therapeutic regimen for patients suffering from mesothelioma. Importantly, we plan to report additional data from the ongoing Phase 1b study later this year.”
Click here to read the entire article
Aduro Biotech, Inc. today announced that the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CRS-207, a novel immuno-oncology product candidate, for the treatment of mesothelioma. This designation potentially allows Aduro seven years of limited marketing exclusivity in the United States if it is the first to obtain FDA marketing approval for mesothelioma, and qualifies the company for grant funding to offset the cost of clinical testing as well as tax credits for certain research and a waiver of the Biologics License Application user fee. The FDA previously granted orphan designation to CRS-207 and GVAX Pancreas for the treatment of pancreatic cancer.
“This is an important step for Aduro as we continue to develop CRS-207 for this very difficult to treat cancer,” said Dirk Brockstedt, Ph.D., senior vice president of research and development at Aduro. “We believe the combination of CRS-207 together with chemotherapy may offer the promise of a potential new therapeutic regimen for patients suffering from mesothelioma. Importantly, we plan to report additional data from the ongoing Phase 1b study later this year.”
Click here to read the entire article
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Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thompson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson-Reuters). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
Monday, December 16, 2013
FDA challenges safety, effectiveness of antibacterial soaps
In many medical treatment scenarios antibacterial soaps have been used and prescribed to treat injured workers. The US FDA has announced that new procedures to substantiate the allegations of the manufacturers as to the effectiveness and safety of these products. Today's post is shared from cidrap.umn.edu
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The US Food and Drug Administration (FDA) today proposed a rule that would require companies that make antibacterial hand soaps and body washes to show that the products are safe for long-term use and are better than regular soap and water in preventing illness and the spread of infections.
Under the FDA's proposal, manufacturers that don't demonstrate the safety and effectiveness would be required to reformulate the products or relabel them to remain on the market, the agency said in a statement today. The FDA detailed its proposal in a 130-page report posted in the Federal Register and is taking comments on it over the next 180 days. Today's rule proposal doesn't apply to hand sanitizers, wipes, or antibacterial products used in healthcare settings. The FDA's proposed rules are part of a broader effort to weigh the benefit and risks of certain active ingredients in antibacterial products, including triclosan in liquid soaps and triclocarban in bar soaps. Scientists have raised concerns about a possible role of widespread antiseptic use in the development of antibiotic resistance. The FDA said in... |
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