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  • Statement published by HHS on FDA Emergency Use Authorization of a COVID-19 Vaccine Candidate

    Statement published by U.S. Department of Health and Human Services on FDA Emergency Use Authorization of a COVID-19 Vaccine Candidate | site |


    (Information contained in U.S. Department of Health and Human Services [HHS] press release dated: December 11, 2020) Today the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Pfizer for its COVID-19 vaccine, the first authorization for a COVID-19 vaccine in the United States. Operation Warp Speed and private sector partners now begin distributing the first allocation of doses to sites designated by the public health jurisdictions and five federal agencies with which OWS and CDC have been working to plan distribution. HHS Secretary Alex Azar and Acting Secretary of Defense Christopher C. Miller released the following statements: “It is nothing short of a medical miracle to have FDA authorization of a vaccine for COVID-19 just over 11 months since the virus was made known to the w...
    See more | Go to post

  • Coronavirus COVID-19 Update - - - FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate

    Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 10, 2020)

    December 10, 2020
    Statement From:
    Commissioner of Food and Drugs - Food and Drug Administration

    Stephen M. Hahn M.D. For nearly 11 months, we have all been learning to live and function in a state of uncertainty, adjusting to a “new normal” as the COVID-19 pandemic has drastically affected the way most of us live, and has also tragically claimed the lives of hundreds of thousands of Americans. We recognize the urgent need for medical countermeasures to diagnose, treat, and prevent this novel virus and have been working diligently to facilitate their development and availability. In particular, the FDA has been working tirelessly with public
    ...
    See more | Go to post

  • Coronavirus COVID-19 Update - - - FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate

    Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 30, 2020) The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc. “In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee, made up of outside scientific and public health experts from around the country, will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA understands there is tremendous public interest regarding vaccines for COVID-19. ...
    See more | Go to post

  • Coronavirus COVID-19 Update - - - FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

    Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 20, 2020)

    The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

    “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and
    ...
    See more | Go to post

  • Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials

    Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials | site |



    (October 12, 2020) - - Today, October 12, 2020, Johnson & Johnson published the following information:



    Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials


    At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world. We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles.

    We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines,
    ...
    See more | Go to post

  • Federal Election Commission Offers Reporting and Filing Webinars for Candidate Committees

    Federal Election Commission Offers Reporting and Filing Webinars for Candidate Committees




    (October 1, 2018) - - Are you running for office or working for a candidate who is running for office? If so, you may want to gain additional information by viewing webinars offered by the Federal Election Commission (FEC).

    The FEC published the following information:

    On October 3 & 4, 2018, the Commission will offer reporting and FECFile webinars to help filers prepare for the busy pre-election filing period. Reporting webinars will address common filing problems and provide answers to questions committees may have as they prepare to file their October Quarterly, October Monthly and Pre-General Election reports, as appropriate. FECFile & e-filing webinars will demonstrate the Commission's free FECFile software and answer questions FECFile users may have concerning the
    ...
    See more | Go to post

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  • Staff Reporter 1
    Statement published by HHS on FDA Emergency Use Authorization of a COVID-19 Vaccine Candidate
    by Staff Reporter 1
    Statement published by U.S. Department of Health and Human Services on FDA Emergency Use Authorization of a COVID-19 Vaccine Candidate | site |


    (Information contained in U.S. Department of Health and Human Services [HHS] press release dated: December 11, 2020) Today the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Pfizer for its COVID-19 vaccine, the first authorization for a COVID-19 vaccine in the United States. Operation Warp Speed and private sector partners now begin distributing the first allocation of doses to sites designated by the public health jurisdictions and five federal agencies with which OWS and CDC have been working to plan distribution. HHS Secretary Alex Azar and Acting Secretary of Defense Christopher C. Miller released the following statements: “It is nothing short of a medical miracle to have FDA authorization of a vaccine for COVID-19 just over 11 months since the virus was made known to the w...
    12-12-2020, 06:08 AM
  • Staff Reporter 1
    Coronavirus COVID-19 Update - - - FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 10, 2020)

    December 10, 2020
    Statement From:
    Commissioner of Food and Drugs - Food and Drug Administration

    Stephen M. Hahn M.D. For nearly 11 months, we have all been learning to live and function in a state of uncertainty, adjusting to a “new normal” as the COVID-19 pandemic has drastically affected the way most of us live, and has also tragically claimed the lives of hundreds of thousands of Americans. We recognize the urgent need for medical countermeasures to diagnose, treat, and prevent this novel virus and have been working diligently to facilitate their development and availability. In particular, the FDA has been working tirelessly with public
    ...
    12-11-2020, 05:22 AM
  • Staff Reporter 1
    Coronavirus COVID-19 Update - - - FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 30, 2020) The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc. “In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee, made up of outside scientific and public health experts from around the country, will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA understands there is tremendous public interest regarding vaccines for COVID-19. ...
    12-01-2020, 12:23 PM
  • Staff Reporter 1
    Coronavirus COVID-19 Update - - - FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 20, 2020)

    The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

    “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and
    ...
    11-21-2020, 11:04 AM
  • Staff Reporter 1
    Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials
    by Staff Reporter 1
    Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials | site |



    (October 12, 2020) - - Today, October 12, 2020, Johnson & Johnson published the following information:



    Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials


    At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world. We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles.

    We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines,
    ...
    10-13-2020, 10:47 PM

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