Light To Guide Our Feet
Light To Guide Our Feet

Menu

Collapse

Search Result

Collapse

Announcement

Collapse
No announcement yet.

What's Going On

Collapse

There are currently 117 users online. 36 members and 81 guests.

Most users ever online was 3,930 at 07:07 PM on 04-20-2019.

53 results in 0.0086 seconds.
Keywords
Members
Tags
fda x
  •  

  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |


    (Information contained in U.S. Food and Drug Administration (FDA) press release: November 21, 2020)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for di
    ...
    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

  • Coronavirus COVID-19 Update - - - FDA Authorizes Drug Combination for Treatment of COVID-19

    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 | site |



    (Information contained in U.S Food and Drug Administration [FDA] press release: November 19, 2020)


    November 19, 2020


    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo w...
    See more | Go to post

  • HHS Secretary Alex Azar Statement on FDA Authorization of First COVID-19 Test for Home Self-Tests

    U.S. Health and Human Services Secretary Alex Azar Statement on FDA Authorization of First COVID-19 Test for Home Self-Tests | site |




    (November 17, 2020) - - On November 17, 2020 the U.S. Department of Health and Human Services (HHS) published the following information: On Tuesday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic at-home test, the Lucira COVID-19 All-In-One Test Kit, a molecular test that provides results in 30 minutes or less and is authorized for use by prescription only. HHS Secretary Alex Azar issued the following statement: “Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options. The Trump Administration has built the world’s largest testing system, and we will continue supporting both the development and manufacturing of cuttin...
    See more | Go to post

  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes First COVID-19 Test for Self-Testing at Home

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home | site |




    (November 17, 2020) - - On November 17, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. “The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic
    ...
    See more | Go to post

  • FDA COVID-19 Update - - - FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs

    U.S. Food and Drug Administration COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs | site |



    (November 17, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information:

    November 17, 2020

    Statement From: Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Emergency use authorizations, or EUAs, are an important tool in our country’s fight against COVID-19 and other public health emergencies. While EUAs have received increased attention during the COVID-19 public health emergency, EUAs are not a new tool to the FDA. I want to take a moment to reaffirm FDA’s commitment to transparency around the EUA process and share some updates on our plan to provide more information about FDA’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines. Earlier this year, we launched the COVID-19 Pandemic Recovery and
    ...
    See more | Go to post

  • FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs

    U.S. Food and Drug Administration Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs| site |


    (November 16, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information: Today, the U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs). The FDA is also approving Stelfonta to treat non-metastatic MCTs located under the dog’s skin (subcutaneous), in particular areas of a dog’s leg. Stelfonta is injected directly into the MCT (intratumoral injection). Stelfonta works by activating a protein that spreads throughout the treated tumor, which disintegrates tumor cells. “This is the first approval for an intratumoral injection to treat non-metastatic mast cell tumors in dogs,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “This appro...
    See more | Go to post

  • FDA Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food Labels

    U.S. Food and Drug Administration Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food Labels | site |



    (November 10, 2020) - - On November 10, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    The U.S. Food and Drug Administration today issued a draft guidance encouraging food manufacturers to voluntarily declare sesame in the ingredient list on food labels. “Many Americans are allergic or sensitive to sesame, and they need the ability to quickly identify products that might contain sesame,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “While most products containing sesame declare it as an ingredient, there are times when sesame is not required to be declared by name on the label, such as when it is used as a ‘flavor’ or ‘spice.’ Other ingredients, like ‘tahini,’ are made by grinding sesame into a past
    ...
    See more | Go to post

  • FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

    U.S. Food and Drug Administration Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development | site |




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


    November 09, 2020

    Statement From: Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations. We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, a
    ...
    See more | Go to post

  • FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

    FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults| site |



    (November 6, 2020) - - On November 6, 2020 the U.S. Food and Drug Administration (FDA) published the following information: Today, the U.S. Food and Drug Administration permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The device provides gentle vibration through touch based on an analysis of heart rate and motion during sleep. “Sleep is an essential part of a person’s daily routine. However, certain adults who have a nightmare disorder or who experience nightmares from PTSD are not able to get the rest they need. Today’s authorization offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary re...
    See more | Go to post

  • Coronavirus - - COVID-19 - - Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

    Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection| site |


    (November 6, 2020) - - On November 6, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. The FDA issued an emergency use authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody. Although the FDA has previously issued EUAs to more than 50 antibody (serology) tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but ...
    See more | Go to post

  • FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order

    FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order| site |



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

    Statement From:
    Commissioner of Food and Drugs - Food and Drug Administration
    Stephen M. Hahn M.D.

    As the U.S. Food and Drug Administration continues our work to address the current pandemic, we are also looking ahead to prepare for the next potential public health emergency. A recent executive order directed the agency, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms. The goal of this work is to ensure the American public is protected against outbreaks of emerging
    ...
    See more | Go to post

  • FDA Coronavirus COVID-19 Update - - October 28, 2020

    FDA Coronavirus COVID-19 Update - - October 28, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: October 28, 2020 | site |



    (October 28, 2020) - - Today, October 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:
    • Today, the FDA updated an immediately in effect guidance, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. This update expands the scope of the guidance to include an additional device type: Gaseous-Phase Carbon-Dioxide Gas Analyzer (product code CCK), which includes capnographs and devices with a capnography feature.
    • Yesterday, the FDA approved two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical
    ...
    See more | Go to post

  • FDA Approves First Treatment for COVID-19

    FDA Approves First Treatment for COVID-19

    U.S. Food and Drug Administration Approves First Treatment for COVID-19 | site |




    (October 22, 2020) - - Today, October 22, 2020, the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered und
    ...
    See more | Go to post

  • Coronavirus COVID-19 Update - - - FDA provides Update on Patient Access to certain REMS Drugs during COVID-19 Public Health Emergency

    Coronavirus COVID-19 Update - - - FDA provides Update on Patient Access to certain REMS Drugs during COVID-19 Public Health Emergency | site |




    (March 22, 2020) - - The U.S. Food and Drug Administration (FDA) published today (March 22, 2020) the following information:

    Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.

    “The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Under these circumstances, undergoing
    ...
    See more | Go to post

Menu

Collapse

Trending

Collapse

  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |


    (Information contained in U.S. Food and Drug Administration (FDA) press release: November 21, 2020)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for di
    ...
    11-23-2020, 09:00 AM
  • 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
    Coronavirus COVID-19 Update - - - FDA Authorizes Drug Combination for Treatment of COVID-19
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 | site |



    (Information contained in U.S Food and Drug Administration [FDA] press release: November 19, 2020)


    November 19, 2020


    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo w...
    11-20-2020, 09:08 AM
  • Staff Reporter 1
    HHS Secretary Alex Azar Statement on FDA Authorization of First COVID-19 Test for Home Self-Tests
    by Staff Reporter 1
    U.S. Health and Human Services Secretary Alex Azar Statement on FDA Authorization of First COVID-19 Test for Home Self-Tests | site |




    (November 17, 2020) - - On November 17, 2020 the U.S. Department of Health and Human Services (HHS) published the following information: On Tuesday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic at-home test, the Lucira COVID-19 All-In-One Test Kit, a molecular test that provides results in 30 minutes or less and is authorized for use by prescription only. HHS Secretary Alex Azar issued the following statement: “Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options. The Trump Administration has built the world’s largest testing system, and we will continue supporting both the development and manufacturing of cuttin...
    11-19-2020, 05:02 AM
  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Authorizes First COVID-19 Test for Self-Testing at Home
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home | site |




    (November 17, 2020) - - On November 17, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. “The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic
    ...
    11-18-2020, 10:39 AM

Menu

Collapse

Menu

Collapse

Working...
X