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  • FDA Approves First Oral Blood Thinning Medication for Children

    FDA Approves First Oral Blood Thinning Medication for Children

    U.S. Food and Drug Administration Approves First Oral Blood Thinning Medication for Children | site |




    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: June 21, 2021) Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism. In addition, Pradaxa was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days, and to preve...
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  • U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 9, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • On Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter at-home diagnostic test for COVID-19. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.
    • On Friday the FDA issued
    ...
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  • FDA Coronavirus COVID-19 Update - - - March 5, 2021

    FDA Coronavirus COVID-19 Update - - - March 5, 2021

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: March 5, 2021 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)

    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 sent letters to 25 firms that produce and issue “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers). In the letters, the FDA is requesting that firms cease producing and issuing such registration certificates. The registration certificates often have the look of an official government document and many display the FDA logo. The FDA does not issue any type of device establishment registration certificate. Registration and listing with FDA does not denote approval or clearance of the establishment or its devices. Some device manufacturers and distributors
    ...
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  • FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy

    FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy

    U.S. Food and Drug Administration Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy | site |



    Drug Is Given Before Chemotherapy to Protect Bone Marrow Function


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 12, 2021) Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer. Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin- dependent kinase 4/6, a type of enzyme. “For patients with extensive-stage small cell lung cancer, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time an...
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  • Excerpt of U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - January 22, 2021

    Excerpt of U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 22, 2021 | site |



    (Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: January 22, 2021)
    • The FDA is reissuing the Emergency Use Authorizations (EUAs) for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. Among other things, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times. Based on the FDA’s review of real-world use of these systems and evidence from adverse events and scientific literature, including studies regarding N95 respirator failures from simula
    ...
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  • FDA Coronavirus COVID-19 Update - - - January 19, 2021

    FDA Coronavirus COVID-19 Update - - - January 19, 2021

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 19, 2021 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: January 19, 2021)


    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - January 15, 2021

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 15, 2021 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 15, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    ...
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  • U.S. Food and Drug Administration Releases Artificial Intelligence/Machine Learning Action Plan

    U.S. Food and Drug Administration Releases Artificial Intelligence/Machine Learning Action Plan | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: January 12, 2021)

    Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,” said Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH). “The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effecti...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - January 5, 2021

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 5, 2021 | site |



    (Information included in U.S. Food and Drug Administration [FDA] press release dated: January 5, 2021)


    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 posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) highlighting authorities that are intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing the FDA’s visibility into drug supply chains.

    The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to:
    Expand the requirement for manufacturers of certain drugs to provide information on permanent discontinuances and interruptions in manufacturing that may lead to a meaningful disruption in supply to the FDA. Include
    ...
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  • FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

    FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 4, 2021)

    January 04, 2021
    Statement From:
    Acting Director - Center for Drug Evaluation and Research
    Deputy Center Director for Operations - Center for Drug Evaluation and Research | CDER
    Patrizia Cavazzoni M.D. Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the past eight years, the U.S. Food and Drug Administration has approved more than twice as many drugs for rare diseases, often referred to as orphan drug
    ...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - December 30, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 30, 2020 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 30, 2020)

    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 published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 pandemic. New materials include social media messages and graphics, consumer information, and health professional messaging. Furthermore, a new COVID-19 Communication Toolkits webpage provides links to all FDA toolkits on COVID-19 topics to help everyone communicate accurate and timely information to patients, the public, and health care professionals.
    ...
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  • FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia

    FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia

    U.S. Food and Drug Administration Approves First Generic of Drug Used to Treat Severe Hypoglycemia | site |


    Agency Supports Development of Complex Generic Drugs to Improve Competition and Access to More Affordable Medicines


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 28, 2020) Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus. The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum (the first part of the small intestine beyond the stomach), small bowel and colon when diminished intestinal motility (reduced ability to move) would be advantageous. “Glucagon for injection has been approved for use in the U.S. for more than 20 years, but unti...
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  • FDA Coronavirus COVID-19 Update - - - December 28, 2020

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

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



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 28, 2020)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • On Dec. 23, the FDA updated the Device Shortage List on our web page that lists Medical Device Shortages During the COVID-19 Public Health Emergency. Specifically, the FDA added the following device types in the testing supplies and equipment category: pipette tips (product codes LXG and PPM) and micro pipettes (product code JRC). The FDA also added clarifying notes and links to more resources in the “Additional Information” column, as well as adding clarity to the categories, such as grouping gloves under “Personal Protective Equipment – Gloves.” The device shortage list reflects the categories of
    ...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - December 22, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 22, 2020 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 22, 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 has posted translations of the Moderna COVID-19 Vaccine fact sheet for recipients and caregivers, and the fact sheet for healthcare providers in languages including: Arabic, Chinese, French, Spanish, Tagalog, and Vietnamese. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
    • The FDA recently approved three abbreviated new drug applications (ANDAs):
    On Dec. 18, one ANDA for etomidate injection, indicated for the induction of general anesthesia. The most common side effects of etomidate injection are venous pain on injection and
    ...
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  • FDA Coronavirus (COVID-19) Update - - - December 21, 2020

    FDA Coronavirus (COVID-19) Update - - - December 21, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 21, 2020 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 21, 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 has posted translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers in languages including: Arabic, Burmese, Cherokee, Chinese (Simplified and Traditional), Chuukese, German, Haitian Creole, Hindi, Hmong, Korean, Mam, Polish, Portuguese, Russian, Spanish, Somali, Tagalog, Vietnamese, and Yiddish. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
    • Today, the agency updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on
    ...
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  • Staff Reporter 1
    FDA Approves First Oral Blood Thinning Medication for Children
    by Staff Reporter 1
    U.S. Food and Drug Administration Approves First Oral Blood Thinning Medication for Children | site |




    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: June 21, 2021) Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism. In addition, Pradaxa was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days, and to preve...
    06-22-2021, 09:08 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 9, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • On Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter at-home diagnostic test for COVID-19. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.
    • On Friday the FDA issued
    ...
    03-10-2021, 02:14 PM
  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - March 5, 2021
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: March 5, 2021 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)

    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 sent letters to 25 firms that produce and issue “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers). In the letters, the FDA is requesting that firms cease producing and issuing such registration certificates. The registration certificates often have the look of an official government document and many display the FDA logo. The FDA does not issue any type of device establishment registration certificate. Registration and listing with FDA does not denote approval or clearance of the establishment or its devices. Some device manufacturers and distributors
    ...
    03-08-2021, 10:10 AM
  • Staff Reporter 1
    FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy
    by Staff Reporter 1
    U.S. Food and Drug Administration Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy | site |



    Drug Is Given Before Chemotherapy to Protect Bone Marrow Function


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 12, 2021) Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer. Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin- dependent kinase 4/6, a type of enzyme. “For patients with extensive-stage small cell lung cancer, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time an...
    02-13-2021, 06:15 AM
  • Staff Reporter 1
    Excerpt of U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - January 22, 2021
    by Staff Reporter 1
    Excerpt of U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 22, 2021 | site |



    (Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: January 22, 2021)
    • The FDA is reissuing the Emergency Use Authorizations (EUAs) for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. Among other things, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times. Based on the FDA’s review of real-world use of these systems and evidence from adverse events and scientific literature, including studies regarding N95 respirator failures from simula
    ...
    01-23-2021, 12:41 AM

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