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13 For whosoever shall call upon the name of the Lord shall be saved. (Romans 10:13 - - - The Holy Bible)

Medicine

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  • U.S. Food and Drug Administration takes new Steps to Strengthen and Modernize Agency’s Oversight and Reporting of Inspections for Sterile Injectable Drugs

    Statement from U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D., on new Steps to Strengthen and Modernize Agency’s Oversight and Reporting of Inspections for Sterile Injectable Drugs



    (November 9, 2018) - - Today, the U.S. Food and Drug Administration (FDA) issued the following statement: Manufacturing inspections are one of the FDA’s most important tools for ensuring the quality of pharmaceutical products used by American patients. Inspections help us to identify manufacturing issues that could pose potential risks to patients, or problems that could contr...
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  • U.S. Department of Veterans Administration Scientists Elected as National Academy of Medicine Members for Outstanding Professional Achievement, Commitment to Service

    U.S. Depart of Veterans Administration Scientists Elected as National Academy of Medicine Members for Outstanding Professional Achievement, Commitment to Service



    Washington, DC - - (November 7, 2018) - - Four senior U.S. Department of Veterans Affairs (VA) researchers were recently elected as new members of the National Academy of Medicine (NAM), one of the highest honors in the fields of health and medicine. VA Drs. Ann McKee, Albert Siu, Lucila Ohno-Machado and Rachel Werner were selected on Oct. 15 by current NAM members for their contributions to medical ...
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  • Statement from U.S. Food and Drug Administration Commissioner Gottlieb on Approval of Dsuvia and the Future Consideration of New Opioids

    Statement from FDA Commissioner Scott Gottlieb, M.D., on Agency’s Approval of Dsuvia and the FDA’s Future Consideration of New Opioids




    (November 2, 2018) - - Today, the U.S. Food and Drug Administration (FDA) published the following Statement from FDA Commissioner Scott Gottlieb: The crisis of opioid addiction is an issue of great concern for our nation. Addressing it is a public health priority for the FDA. The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain. As part of these considerations, there’s been an important and robust public debate leading up to the regulatory decision on...
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  • U.S. Food and Drug Administration Launches Global Operation to Crack Down on Websites Selling Illegal, Potentially Dangerous Drugs; including Opioids

    U.S. Food and Drug Administration Launches Global Operation to Crack Down on Websites Selling Illegal, Potentially Dangerous Drugs; including Opioids



    Illegally marketed opioids and drugs claiming to treat cancer and HIV are among the products targeted, along with the websites that sell them


    (October 23, 2018) - - The U.S. Food and Drug Administration (FDA), in partnership with international regulatory and law enforcement agencies, acted this week to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S....
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  • Centers for Medicare and Medicaid Services Model Addresses Opioid Misuse among Expectant and New Mothers

    Centers for Medicare and Medicaid Services Model Addresses Opioid Misuse among Expectant and New Mothers



    Goals are to improve quality of care, increase access to treatment based on state-specific needs, and reduce expenditures


    (October 23, 2018) - - Today the Centers for Medicare & Medicaid Services (CMS) announced the Maternal Opioid Misuse (MOM) model, an important step in advancing the agency’s multi-pronged strategy to combat the nation’s opioid crisis. The model addresses the need to better align and coordinate care of pregnant and postpartum Medicaid beneficiaries with
    ...
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  • Remarks from FDA Commissioner Scott Gottlieb as Prepared for Delivery at the Brookings Institution on the Release of the Biosimilars Action Plan

    Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan


    (July 18, 2018) - - Statement: Our ability to build a market for safe, effective biosimilar products is key for patients and our nation’s health care system. It’s a key to promoting access and reducing health care costs. And it’s a key to advancing public health. But I’m worried that the market for these products still isn’t established. The ability for these products to penetrate clinical practice, and gain acceptance, is still not firm. That doesn’t mean that the future doesn’t hold a lot of promise for biosimilars. It just means that the future is uncertain. And the policy and regulatory decisions that we make today are going to have a lot to do with whether we realize the promise for this new category of products. Or if we see the opportunities we once envisioned go unrealized. We know that biologics are used to treat many serious and life-threatening diseases. They’ve become a mainstay in the treatment of cancer and autoimmune conditions. They’re also expensive. While less than 2 percent of Americans use biologics, they represent 40 percent of total spending on prescription drugs. So, enabling a path to competition for biologics from biosimilars is a key to reducing costs and to facilitating more innovation. By enabling a path for competition from biosimilars, we also give innovators an added incentive to invest in further research that’ll lead to the discovery of even better drugs that deliver additional benefits for patients. At the FDA, we’re focused on advanci...
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  • U.S. Food and Drug Administration Warns Companies Selling Illegal, Unapproved Kratom Products

    U.S. Food and Drug Administration Warns Companies Selling Illegal, Unapproved Kratom Products Marketed for Opioid Cessation, Pain Treatment and Other Medical Uses




    (May 22, 2018) - - Today, the U.S. Food and Drug Administration published the following information:

    The U.S. Food and Drug Administration has issued warning letters to three marketers and distributors of kratom products – Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri – for illegally selling unapproved kratom-containing drug products with unproven claims
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  • FDA Approves New Uses for Two Drugs Administered Together for the Treatment of BRAF-positive Anaplastic Thyroid Cancer

    FDA Approves New Uses for Two Drugs Administered Together for the Treatment of BRAF-positive Anaplastic Thyroid Cancer



    (May 4, 2018) - - The U.S. Food and Drug Administration (FDA) approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive). “This is the first FDA-approved treatment for patients with this aggressive form of thyroid cancer, and...
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  • U.S. Food and Drug Administration says Colorado Unapproved Drug and Dietary Supplement Makers Ordered to Cease Operations for Federal Violations

    U.S. Food and Drug Administration says Colorado Unapproved Drug and Dietary Supplement Makers Ordered to Cease Operations for Federal Violations





    Washington, DC - - (March 14, 2017) - - Today, the U.S. Food and Drug Administration published the following information: Yesterday, U.S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren, requiring Floren’s businesses to immediately cease opera...
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  • U.S. Food and Drug Administration Approves First Treatment for Frequent Urination at Night due to Overproduction of Urine

    U.S. Food and Drug Administration Approves First Treatment for Frequent Urination at Night due to Overproduction of Urine



    March 3, 2017


    The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition. “Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,” said Hylton
    ...
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