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

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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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  • Mutual Recognition Promises New Framework for Pharmaceutical Inspections for United States and European Union

    Mutual Recognition Promises New Framework for Pharmaceutical Inspections for United States and European Union





    March 2, 2017


    The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities. The amended agreement ‎represents the culmination of nearly three years of U.S. Food and Dr
    ...
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  • U.S. Food and Drug Administration Approves Odactra for House Dust Mite Allergies

    U.S. Food and Drug Administration Approves Odactra for House Dust Mite Allergies




    March 1, 2017


    The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 years of age. “House dust mite allergic disease can negatively impact a person’s quality of life,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Researc
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  • U.S. Department of Veterans Affairs Study Highlights Benefits of Enhanced Aspirin in Preventing Certain Cancers

    U.S. Department of Veterans Affairs Study Highlights Benefits of Enhanced Aspirin in Preventing Certain Cancers





    March 3, 2017


    Washington, DC - - (March 1, 2017) - - Researchers know of aspirin’s benefits in preventing certain ailments — from cardiovascular disease to most recently colorectal cancer. But while the link to those two conditions was made, researchers also questioned how and if this “wonder drug” could work to ward
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  • U.S. Food and Drug Administration Approves Xermelo for Carcinoid Syndrome Diarrhea

    U.S. Food and Drug Administration Approves Xermelo for Carcinoid Syndrome Diarrhea



    February 28, 2017


    Washington, DC - - (February 28, 2017) - - The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled.

    Carcinoid syndrome is a cluster of symptoms
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  • U. S. Food and Drug Administration Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and Sepsis

    U. S. Food and Drug Administration Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and Sepsis



    February 27, 2017


    Washington, DC - - (February 23, 2017) - - The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. This is the first test to use procalcitonin (PCT), a protein associated with the body’s
    ...
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A Warning to Christian Ministers

A Warning to Christian Ministers

By
Pastor Clarence William
...

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