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  • FDA Coronavirus COVID-19 Update - - - FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators | site |


    (Information contained in U.S. Food and Drug Administration press release: November 25, 2020)

    Today, the U.S. Food and Drug Administration (FDA) issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply of respirators during the COVID-19 public health emergency. The immediately-in-effect guidance provides the FDA’s thinking and recommendations regarding the use of bioburden reduction systems that use dry heat to reduce the bioburden, or amount of microorganisms present, on certain respirators for reuse by a single user. Bioburden reduction systems are intended to achieve a certain level in microbial reduction on a device; these are not decontamina
    ...
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  • U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 24, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 24, 2020 | site |




    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 24, 2020)

    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 today published Face Masks, Including Surgical Masks, and Respirators for COVID-19, a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks, and respirators. The topics covered in this new page include:
      • The basics on face masks, surgical masks, and respirators
      • Using face masks, surgical masks, and respirators
      • Shortages of face masks, surgical masks, and respirators during COVID-19
      • The Emergency Use Authorizations for face masks, surgical masks, and respirators
      • Manufacturing and importing face masks, surgical masks, and respirators during
    ...
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  • U.S. Food and Drug Administration Approves First Drug to Treat Rare Metabolic Disorder

    U.S. Food and Drug Administration Approves First Drug to Treat Rare Metabolic Disorder | site |


    Approval is for primary hyperoxaluria type 1, which causes recurrent kidney stones and loss of kidney function


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020) Today, the U.S. Food and Drug Administration approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder. This approval is a cumulation of the work of experts and community members coordinated by the Oxalosis & Hyperoxaluria Foundation and the Kidney Health Initiative. “The approval of Oxlumo represents a great triumph of community involvement to address a rare disease. It is a result of input from patients, treating physicians, experts and sponsors at a patient-focused drug development meeting and through other collaborative efforts,” said Norman Stockbridge, M.D., Ph.D., director of the ...
    See more | Go to post

  • FDA Coronavirus COVID-19 Update - - - November 23, 2020

    FDA Coronavirus COVID-19 Update - - - November 23, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 23, 2020 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020)

    The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
    • On Nov. 20, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American
    ...
    See more | Go to post

  • FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

    FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

    U.S. Food and Drug Administration Expands Approval of Influenza Treatment to Post-Exposure Prevention | site |


    (Information contained in U.S. Food and Drug Administration press release: November 23, 2020)

    Today, the U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. “This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra
    ...
    See more | Go to post

  • 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
    ...
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  • 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...
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  • U.S. Food and Drug Administration Releases New Outbreak Investigation Table

    in Food

    U.S. Food and Drug Administration Releases New Outbreak Investigation Table

    U.S. Food and Drug Administration Releases New Outbreak Investigation Table | site |



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


    FDA Releases New Outbreak Investigation Table


    New tool will communicate outbreak investigations in early stages



    November 18, 2020

    Statement From:
    Deputy Commissioner for Food Policy and Response - Food and Drug Administration
    Frank Yiannas

    The U.S. Food and Drug Administration is committed to transparency and keeping the public and stakeholders informed of our work upholding the safety of our food supply. As part of this continued commitment, today we are releasing a new tool to communicate foodborne illness outbreak information frequently and as soon as the FDA begins an outbreak investigation – prior to a public health advisory or recall of a certain
    ...
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  • FDA Coronavirus COVID-19 Update - - - November 17, 2020

    FDA Coronavirus COVID-19 Update - - - November 17, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 17, 2020 | site |



    (November 17, 2020) - - On November 17, 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 reaffirmed its commitment to transparency around the EUA process and shared updates on its plan to provide more information about the agency’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines, as part of our COVID-19 response. FDA is taking additional steps to promote transparency and public confidence in the agency’s scientific review process and the appropriate use of these products authorized for emergency use by posting, to the extent appropriate and permitted by law, the scientific reviews for EUAs issued, revised, or revoked
    ...
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  • 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
    ...
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  • FDA Coronavirus COVID-19 Update - - - November 16, 2020

    FDA Coronavirus COVID-19 Update - - - November 16, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 16, 2020 | site |



    (November 16, 2020) - - The U.S. Food and Drug Administration (FDA) published (today) 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, FDA updated its guidance on investigational COVID-19 convalescent plasma. The updated guidance extends the period of enforcement discretion through the end of February 2021. This extension will allow continued access to convalescent plasma for the treatment of hospitalized COVID-19 patients while blood establishments develop the necessary operating procedures to manufacture the plasma consistent with the EUA. The guidance also includes a new recommendation that authorized COVID-19 convalescent plasma not be collected from individuals who have received an investigational COVID-19 vaccine.
    • The agency
    ...
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  • 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
    ...
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  • U.S. FDA Coronavirus COVID-19 Update - - - November 10, 2020

    U.S. FDA Coronavirus COVID-19 Update - - - November 10, 2020

    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - November 10, 2020 | 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 announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • On November 12, the FDA will host a virtual FDA Grand Rounds: Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve? This presentation provides an overview of the FDA’s research to evaluate the ability of facial coverings to reduce the spread of infection and how the FDA is developing a comprehensive risk-assessment tool to predict the probability of infection with individuals wearing a non-surgical face mask or cloth face covering; given the characteristics of non-surgical face masks, the population, and the pathogen. This presentation discusses how the
    ...
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  • Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

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



    (November 9, 2020) - - On November 9, 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 investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivima
    ...
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  • FDA Approves Lotion for Nonprescription Use to Treat Head Lice

    FDA Approves Lotion for Nonprescription Use to Treat Head Lice

    U.S. Food and Drug Administration Approves Lotion for Nonprescription Use to Treat Head Lice| site |



    (October 27, 2020) - - The U.S. Food and Drug Administration (FDA) published today, October 27, 2020, the following information:

    Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012.

    “The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” said Theresa Michele, M.D., acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands access to another
    ...
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  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators | site |


    (Information contained in U.S. Food and Drug Administration press release: November 25, 2020)

    Today, the U.S. Food and Drug Administration (FDA) issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply of respirators during the COVID-19 public health emergency. The immediately-in-effect guidance provides the FDA’s thinking and recommendations regarding the use of bioburden reduction systems that use dry heat to reduce the bioburden, or amount of microorganisms present, on certain respirators for reuse by a single user. Bioburden reduction systems are intended to achieve a certain level in microbial reduction on a device; these are not decontamina
    ...
    11-27-2020, 10:13 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 24, 2020
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 24, 2020 | site |




    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 24, 2020)

    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 today published Face Masks, Including Surgical Masks, and Respirators for COVID-19, a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks, and respirators. The topics covered in this new page include:
      • The basics on face masks, surgical masks, and respirators
      • Using face masks, surgical masks, and respirators
      • Shortages of face masks, surgical masks, and respirators during COVID-19
      • The Emergency Use Authorizations for face masks, surgical masks, and respirators
      • Manufacturing and importing face masks, surgical masks, and respirators during
    ...
    11-25-2020, 05:42 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Approves First Drug to Treat Rare Metabolic Disorder
    by Staff Reporter 1
    U.S. Food and Drug Administration Approves First Drug to Treat Rare Metabolic Disorder | site |


    Approval is for primary hyperoxaluria type 1, which causes recurrent kidney stones and loss of kidney function


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020) Today, the U.S. Food and Drug Administration approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder. This approval is a cumulation of the work of experts and community members coordinated by the Oxalosis & Hyperoxaluria Foundation and the Kidney Health Initiative. “The approval of Oxlumo represents a great triumph of community involvement to address a rare disease. It is a result of input from patients, treating physicians, experts and sponsors at a patient-focused drug development meeting and through other collaborative efforts,” said Norman Stockbridge, M.D., Ph.D., director of the ...
    11-24-2020, 11:35 AM
  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - November 23, 2020
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 23, 2020 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020)

    The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
    • On Nov. 20, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American
    ...
    11-24-2020, 11:23 AM
  • Staff Reporter 1
    FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
    by Staff Reporter 1
    U.S. Food and Drug Administration Expands Approval of Influenza Treatment to Post-Exposure Prevention | site |


    (Information contained in U.S. Food and Drug Administration press release: November 23, 2020)

    Today, the U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. “This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra
    ...
    11-23-2020, 11:37 PM

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