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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - Daily Roundup May 28, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020| site |



    (May 28, 2020) - - Today (May 28, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • The FDA issued an Emergency Use Authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS). This product uses vapor hydrogen peroxide (VHP) to decontaminate compatible N95 respirators that are, or potentially are, contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. N95 respirators containing cellulose-based materials
    ...
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  • U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests

    U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests| site |



    (May 21, 2020) - - The U.S. Food and Drug Administration (FDA) published today (May 21, 2020) the following information:

    Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on
    ...
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  • U.S. Food and Drug Administration Expedites Review of Diagnostic Tests to Combat COVID-19

    U.S. Food and Drug Administration Expedites Review of Diagnostic Tests to Combat COVID-19 | site |




    (March 30, 2020) - - Today (March 30, 2020), the U.S. Food and Drug Administration (FDA) published the following information:



    March 30, 2020

    Statement From:

    Commissioner of Food and Drugs - Food and Drug Administration

    Stephen M. Hahn M.D.

    The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed. Moreover, as in previous...
    See more | Go to post

  • FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases

    U.S. Food and Drug Administration Approves First Treatment for Group of Progressive Interstitial Lung Diseases| site |



    (March 9, 2020) - - Today, the U.S. Food and Drug Administration (FDA) published the following information:

    The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time.

    “The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” said Banu Karimi-Shah, M.D., acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases
    ...
    See more | Go to post

  • Coronavirus Update - - - FDA Steps to Ensure Quality of Foreign Products

    Coronavirus Update - - - FDA Steps to Ensure Quality of Foreign Products

    Coronavirus Update: U.S. Food and Drug Administration Steps to Ensure Quality of Foreign Products| site |



    (February 24, 2020) - - Today (February 24, 2020), the U.S. Food and Drug Administration (FDA) published the following information:


    Coronavirus Update: FDA steps to ensure quality of foreign products


    February 24, 2020

    Statement From:

    Commissioner of Food and Drugs - Food and Drug Administration
    Stephen M. Hahn M.D.
    Associate Commissioner for Regulatory Affairs - Office of Regulatory Affairs
    Judith A. McMeekin Pharm.D.


    Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak: COVID-19. We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply...
    See more | Go to post

  • U.S. Food and Drug Administration takes Action with Indian Government to Protect Consumers From Illicit Medical Products

    U.S. Food and Drug Administration takes Action with Indian Government to Protect Consumers From Illicit Medical Products | site |



    First Bilateral Enforcement Operation with India Stopped Approximately 500 Shipments Through International Mail


    (February 18, 2020) - - Today, the U.S. Food and Drug Administration (FDA) published the following information:

    The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January.

    “With standards and regulations varying in each country, U.S. consumers face hazards when they order drugs and other FDA-regulated products from unauthorized foreign sources and receive them through the international
    ...
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  • Millennium Health Donates Data to Help Fight the Drug Overdose Crisis

    Millennium Health Donates Data to Help Fight the Drug Overdose Crisis

    Millennium Health Donates Data to Help Fight the Drug Overdose Crisis| site |



    (January 7, 2020) - - Today (January 7, 2020), the U.S. Department of Health and Human Services published the following information: The U.S. Department of Health and Human Services (HHS) today is announcing an agreement with Millennium Health to provide near real-time drug testing data that will enhance efforts and targeted approaches in fighting the overdose crisis in the U.S. This donation will improve HHS’ work with state and local officials on drug trends in their areas to target coordination of preventive healthcare resources to avoid overdoses. The data donated from Millennium Health’s Emerging Threat Intelligence Program will include regular reporting of drug use trends from definitive urine drug-test results obtained from all 50 states, the District of Columbia and multiple medical practice types with a unique capability to identify community level indicators of ill...
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  • Centers for Medicare and Medicaid Services discuss Delay of Inclusion of Territories in Medicaid Drug Rebate Program; Covered Outpatient Drug Interim Final Rule, CMS 2345-IFC3

    Centers for Medicare and Medicaid Services discuss Delay of Inclusion of Territories in Medicaid Drug Rebate Program; Covered Outpatient Drug Interim Final Rule (CMS 2345-IFC3) | site |



    (November 21, 2019) - - Today (November 21, 2019), the Centers for Medicare & Medicaid Services published the following information:

    Delay of Inclusion of Territories in Medicaid Drug Rebate Program; Covered Outpatient Drug Interim Final Rule (CMS 2345-IFC3) On February 1, 2016, the Centers for Medicare & Medicaid Services (CMS) published the “Medicaid Program; Covered Outpatient Drug” Final Rule with Comment Period (CMS-2345-FC) in the Federal Register (81 FR 5170). As part of that final rule with comment period, we amended the regulatory definitions of “States” and “United States” to include the U.S. Territories (American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands) beginning A
    ...
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  • FDA Approves First Targeted Therapy to Treat Patients with Painful Complication of Sickle Cell Disease

    U.S. Food and Drug Administration Approves First Targeted Therapy to Treat Patients with Painful Complication of Sickle Cell Disease | site |



    (November 15, 2019) - - The U.S. Food and Drug Administration (FDA) published (today) the following information: Today, the U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older. “Hope has never been higher for people living with sickle cell disease and their families and supporters, with a pipeline of new treatments on the horizon, like the one being approved today, and several initiatives underway to better utilize current tools in the battle against the painful and deadly blood disorder,” said Acting FDA Commissioner Adm. Brett P. Giroir, M.D. “The opportunity
    ...
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  • U.S. Food and Drug Administration Authorizes Emergency Use of First Ebola Fingerstick Test with Portable Reader

    U.S. Food and Drug Administration Authorizes Emergency Use of First Ebola Fingerstick Test with Portable Reader



    (November 9, 2018) - - The U.S. Food and Drug Administration published (today) the following information:

    Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated. The test, called the DPP Ebola Antigen System, is used with blood specimens, including capillary “fingerstick” whole blood, from individuals with signs and symptoms of Ebola virus disease (EVD) in addition to
    ...
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  • Statement From Attorney General Sessions on the Drug Enforcement Administration’s 2018 National Drug Threat Assessment

    Statement From Attorney General Sessions on the Drug Enforcement Administration’s 2018 National Drug Threat Assessment



    (November 2, 2018) - - The U.S. Department of Justice published (today) the following statement from Attorney General Jeff Sessions: Today, the Drug Enforcement Administration (DEA) released its 2018 National Drug Threat Assessment, a comprehensive, strategic assessment of the illicit drug threats facing the United States. Attorney General Sessions made the following statement about the report: “This new report from the DEA confirms that transnational drug cartels and foreign drug labs, working with street gangs, are flooding our communities with drugs like heroin, fentanyl, cocaine, and methamphetamines,” Attorney General Sessions said. “But under the Trump Administration, we are hammering these groups. I have restored commonsense criminal charging and sentencing...
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  • Statement from U.S. Food and Drug Administration Commissioner Scott Gottlieb on the FDA’s new Consideration of Labeling for Sesame Allergies

    Statement from U.S. Food and Drug Administration Commissioner Scott Gottlieb on the FDA’s new Consideration of Labeling for Sesame Allergies



    (October 29, 2018) - - Today, the U.S. Food and Drug Administration (FDA) published the following statement from FDA Commissioner Scott Gottlieb, M.D.: Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods. In particular, the undeclared presence of allergens in foods – the leading reason for food recalls – continues t...
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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. consumers.

    This effort was part of Operation Pangea XI, the eleventh annual International Internet Week of Action (IIWA). This is a global cooperative effort, led by Interpol, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products
    ...
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  • U.S. Department of Justice Selects Cleveland for Strike Force Targeting Drug Trafficking and Violent Crime

    U.S. Department of Justice Selects Cleveland for Strike Force Targeting Drug Trafficking and Violent Crime



    (October 26, 2018) - - Deputy Attorney General Rod Rosenstein joined United States Attorney Justin Herdman, federal and local law enforcement officials today to announce a new strike force to target drug trafficking and violent crime in Cleveland. The Cleveland Organized Crime Drug Enforcement Task Force Strike Force will bring together more than 200 local police, federal agents and prosecutors to work side-by-side to strengthen public safety. The strike force’s mission will be to disrupt and dismantle major criminal organizations and their subsidiaries trafficking narcotics, weapons, humans and the proceeds of their crimes. Cooperative investigations will be focused on dissolving these organizations, their financial infrastructure, and the violence that accompanies their activities....
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  • U.S. Food and Drug Administration Approves New DNA-based Test to Determine Blood Compatibility

    U.S. Food and Drug Administration Approves New DNA-based Test to Determine Blood Compatibility



    Test is first approved to report genotypes as final results


    (October 11, 2018) - - The U.S. Food and Drug Administration today approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. ID CORE XT is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results. “The approval of the ID CORE XT Test can streamline blood compatibility testing and provides an additional alternative to testing blood with antisera,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We know that DNA testing holds great promise – to prov
    ...
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  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - Daily Roundup May 28, 2020
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020| site |



    (May 28, 2020) - - Today (May 28, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • The FDA issued an Emergency Use Authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS). This product uses vapor hydrogen peroxide (VHP) to decontaminate compatible N95 respirators that are, or potentially are, contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. N95 respirators containing cellulose-based materials
    ...
    05-29-2020, 07:26 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests
    by Staff Reporter 1
    U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests| site |



    (May 21, 2020) - - The U.S. Food and Drug Administration (FDA) published today (May 21, 2020) the following information:

    Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on
    ...
    05-26-2020, 05:09 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Expedites Review of Diagnostic Tests to Combat COVID-19
    by Staff Reporter 1
    U.S. Food and Drug Administration Expedites Review of Diagnostic Tests to Combat COVID-19 | site |




    (March 30, 2020) - - Today (March 30, 2020), the U.S. Food and Drug Administration (FDA) published the following information:



    March 30, 2020

    Statement From:

    Commissioner of Food and Drugs - Food and Drug Administration

    Stephen M. Hahn M.D.

    The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed. Moreover, as in previous...
    04-01-2020, 02:20 AM
  • Staff Reporter 1
    FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases
    by Staff Reporter 1
    U.S. Food and Drug Administration Approves First Treatment for Group of Progressive Interstitial Lung Diseases| site |



    (March 9, 2020) - - Today, the U.S. Food and Drug Administration (FDA) published the following information:

    The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time.

    “The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” said Banu Karimi-Shah, M.D., acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases
    ...
    03-10-2020, 05:19 AM
  • Staff Reporter 1
    Coronavirus Update - - - FDA Steps to Ensure Quality of Foreign Products
    by Staff Reporter 1
    Coronavirus Update: U.S. Food and Drug Administration Steps to Ensure Quality of Foreign Products| site |



    (February 24, 2020) - - Today (February 24, 2020), the U.S. Food and Drug Administration (FDA) published the following information:


    Coronavirus Update: FDA steps to ensure quality of foreign products


    February 24, 2020

    Statement From:

    Commissioner of Food and Drugs - Food and Drug Administration
    Stephen M. Hahn M.D.
    Associate Commissioner for Regulatory Affairs - Office of Regulatory Affairs
    Judith A. McMeekin Pharm.D.


    Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak: COVID-19. We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply...
    02-26-2020, 09:42 AM

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