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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 Statement on Vaccines and Related Biological Products Advisory Committee Meeting

    U.S. Food and Drug Administration Statement on Vaccines and Related Biological Products Advisory Committee Meeting | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 17, 2020)


    Statement From:
    Commissioner of Food and Drugs - Food and Drug Administration
    Stephen M. Hahn M.D.
    Director - Center for Biologics Evaluation and Research (CBER)
    Peter Marks M.D., PhD.

    Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.






    The FDA, an agency
    ...
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  • U.S. Food and Drug Administration Statement on Vaccines and Related Biological Products Advisory Committee Meeting

    U.S. Food and Drug Administration Statement on Vaccines and Related Biological Products Advisory Committee Meeting | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release statement: December 11, 2020)


    December 11, 2020

    Statement From:

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

    Director - Center for Biologics Evaluation and Research (CBER)
    Peter Marks M.D., PhD. Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.
    ...
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  • DHS Issues Detention Order on Cotton Products Made by Xinjiang Production and Construction Corps Using Prison Labor

    U.S. Department of Homeland Security Issues Detention Order on Cotton Products Made by Xinjiang Production and Construction Corps Using Prison Labor | site |



    (Information contained in U.S. Department of Homeland Security (DHS) press release: December 2, 2020) The U.S. Department of Homeland Security announced today that U.S. Customs and Border Protection (CBP) personnel at all U.S. ports of entry will detain shipments containing cotton and cotton products originating from the Xinjiang Production and Construction Corps (XPCC). CBP’s Office of Trade directed the issuance of a Withhold Release Order (WRO) against cotton products made by the XPCC based on information that reasonably indicates the use of forced labor, including convict labor. The WRO applies to all cotton and cotton products produced by the XPCC and its subordinate and affiliated entities as well as any products that are made in whole or in part with or derived from that cotton, such ...
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  • HHS and DOD Award 11.6 Million Dollars Contract to Puritan Medical Products to Boost U.S. Production of Swabs for Cue Health COVID-19 Tests

    HHS and DOD Award $11.6 Million Contract to Puritan Medical Products to Boost U.S. Production of Swabs for Cue Health COVID-19 Tests | site |


    (Information contained in U.S. Department of Health and Human Services press release: November 23, 2020) The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DOD) have jointly awarded an $11.6 million contract to Puritan Medical Products Company, LLC, to expand domestic production capacity of Cue Sample Wands, the nasal swabs used exclusively with the COVID-19 cartridge-based molecular testing system developed and manufactured by Cue Health, Inc. The test generates results in about 20 minutes at the point-of-care (POC). Awarded November 19, the new contract will allow Puritan Medical to expedite upgrades at its Maine facility and increase production capability of Cue’s nasal swabs to 3 million per month by March 2021. These efforts support the federal government’s procurement of 6 millio...
    See more | Go to post

  • CDC says 50.6 Million U.S. Adults Currently Use Tobacco Products

    CDC says 50.6 Million U.S. Adults Currently Use Tobacco Products

    Centers for Disease Control and Prevention says 50.6 Million U.S. Adults Currently Use Tobacco Products | site |


    Cigarettes remain most used tobacco product in 2019


    (Information contained in Centers for Disease Control and Prevention [CDC] press release: November 19, 2020)

    Findings from a Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report released today show that approximately 1 in 5 U.S. adults reported currently using a tobacco product in 2019, with about 80% of those adults reporting that they use combustible products such as cigarettes. To assess recent national estimates of tobacco product use among U.S. adults 18 years or older, CDC analyzed data from the 2019 National Health Interview Survey. The survey measured use of five tobacco products: cigarettes, cigars (cigars, cigarillos, or filtered little cigars), pipes (regular pipes, water pipes, or hookahs), e-cigarettes, and smokeless tobacco (ch
    ...
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  • Coronavirus COVID-19 Update - - - FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

    Coronavirus COVID-19 Update - - - FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators | site |




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

    Today, the U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing. “The FDA’s new actions will mean America can make more ventilators during this crisis,” said Health and Human Services Secretary Alex Azar. “Today’s actions are another step by the FDA and HHS to eliminate every possible barrier to the all-of-America approach that President Trump has called for. With this boost from the FDA, medical device makers can more easily make changes to existing products, such as changes
    ...
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  • U.S. Department of Health and Human Services Solicits Proposals for Development of Medical Products for Novel Coronavirus

    U.S. Department of Health and Human Services Solicits Proposals for Development of Medical Products for Novel Coronavirus| site |




    (March 6, 2020) - - Today, the U.S. Department of Health and Human Services published the following information:

    As part of the government-wide effort to mitigate the spread of COVID-19 in U.S. communities, the U.S. Department of Health and Human Services (HHS) has updated a broad agency announcement (BAA) to focus specifically on products to diagnose, prevent or treat coronavirus infections.

    The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), issued the BAA, BAA-18-100-SOL-00003-Amendment 13, to solicit proposals for advanced development and licensure of COVID-19 diagnostics, vaccines, or medicines such as therapeutics or antivirals. “Amid the expanding global outbreak of COVID-19, Americans n
    ...
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  • Council for International Organizations of Medical Sciences addresses Quality of Medical Products

    Council for International Organizations of Medical Sciences addresses Quality of Medical Products| site |




    (February 28, 2020) - - As the world rushes to discover and develop medicines and vaccines to fight Coronavirus COVID-19, the quality of the medicines and vaccines is an important consideration. In a special newsletter dated February 20, 2020 the Council for International Organizations of Medical Sciences (CIOMS) addresses the quality issue. The special newsletter is located online at:

    https://cioms.ch/wp-content/uploads/...2020_Final.pdf or press HERE
    ...
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  • 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...
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  • 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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  • U.S. State Department Advisory on the Export of Metals Products to Iran

    U.S. State Department Advisory on the Export of Metals Products to Iran

    U.S. State Department Advisory on the Export of Metals Products to Iran| site |


    (December 16, 2019) - - Today, the U.S. Department of State's Office of the Spokesperson provided the following information: The U.S. Department of State is issuing this advisory to alert persons globally to the U.S. sanctions risks for parties involved in transfers or exports to Iran of graphite electrodes and needle coke, which are essential materials for Iran’s steel industry. The U.S. Government is taking strong action to deny the Government of Iran revenue derived from Iran’s steel sector, since such funds may be used to advance the Iranian regime’s malign behavior, including its proliferation programs, campaigns of regional aggression, and support for terrorist groups. Transfers or exports to Iran of graphite electrodes or needle coke create significant sanctions risk for entities and individuals, including but not limited to producers and exporters of graphite electrodes ...
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  • U.S. Centers for Disease Control and Prevention says 6.2 Million Middle and High School Students used Tobacco Products in 2019

    U.S. Centers for Disease Control and Prevention says 6.2 Million Middle and High School Students used Tobacco Products in 2019 | site |


    CDC says E-cigarettes most commonly used tobacco product


    (December 5, 2019) - - Today, the U.S. Centers for Disease Control and Prevention published the following information:

    About 6.2 million U.S. middle and high school students were current (past 30-day) users of some type of tobacco product in 2019, according to new National Youth Tobacco Survey (NYTS) data released in today’s Morbidity and Mortality Weekly Report.

    The survey found that about 1 in 3 high school students (4.7 million) and about 1 in 8 middle school students (1.5 million) are current tobacco users.




    Tobacco Product Use Among High School Students



    For the sixth year in a row, e-cigarettes were the most commonly used tobacco product among high school (27.5%) and...
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  • Centers for Disease Control, States Update Number of Cases of Lung Injury Associated with use of E-cigarette, or Vaping, Products

    Centers for Disease Control, States Update Number of Cases of Lung Injury Associated with use of E-cigarette, or Vaping, Products| site |


    (October 31, 2019) - - Today, the Centers for Disease Control and Prevention (CDC) published the following information:

    CDC today announced the updated number of confirmed and probable lung injury cases and deaths associated with the use of e-cigarette, or vaping, products.

    Patients with Lung Injury
    Deaths
    • 37 deaths have been confirmed in 24 states and the District of Columbia: Alabama, California (3), Connecticut, Delaware, Florida,
    ...
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  • Centers for Disease Control and Prevention says THC Products May Play a Role in Outbreak of Lung Injury Associated with E-cigarette Use, or Vaping

    Centers for Disease Control and Prevention says THC Products May Play a Role in Outbreak of Lung Injury Associated with E-cigarette Use, or Vaping| site |


    Investigation ongoing, no single product linked to all cases, but patterns emerge


    (September 27, 2019) - - Today, the Centers for Disease Control and Prevention (CDC) published the following information:

    The latest findings from the investigation into lung injuries associated with e-cigarette use, or vaping, suggest THC products play a role in the outbreak. Most of the people (77%) in this outbreak reported using THC-containing products, or both THC-containing products and nicotine-containing products, according to a report published today in the CDC’s Morbidity and Mortality Weekly Report (MMWR). Though the investigation is ongoing and the cause remains unknown at this time, today’s report provides the first national comprehensive data on the characteristics of cases reported to
    ...
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  • Staff Reporter 1
    FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine
    by Staff Reporter 1
    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
    ...
    01-05-2021, 02:20 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Statement on Vaccines and Related Biological Products Advisory Committee Meeting
    by Staff Reporter 1
    U.S. Food and Drug Administration Statement on Vaccines and Related Biological Products Advisory Committee Meeting | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 17, 2020)


    Statement From:
    Commissioner of Food and Drugs - Food and Drug Administration
    Stephen M. Hahn M.D.
    Director - Center for Biologics Evaluation and Research (CBER)
    Peter Marks M.D., PhD.

    Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.






    The FDA, an agency
    ...
    12-18-2020, 02:00 PM
  • Staff Reporter 1
    U.S. Food and Drug Administration Statement on Vaccines and Related Biological Products Advisory Committee Meeting
    by Staff Reporter 1
    U.S. Food and Drug Administration Statement on Vaccines and Related Biological Products Advisory Committee Meeting | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release statement: December 11, 2020)


    December 11, 2020

    Statement From:

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

    Director - Center for Biologics Evaluation and Research (CBER)
    Peter Marks M.D., PhD. Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.
    ...
    12-12-2020, 02:53 AM
  • Staff Reporter 1
    DHS Issues Detention Order on Cotton Products Made by Xinjiang Production and Construction Corps Using Prison Labor
    by Staff Reporter 1
    U.S. Department of Homeland Security Issues Detention Order on Cotton Products Made by Xinjiang Production and Construction Corps Using Prison Labor | site |



    (Information contained in U.S. Department of Homeland Security (DHS) press release: December 2, 2020) The U.S. Department of Homeland Security announced today that U.S. Customs and Border Protection (CBP) personnel at all U.S. ports of entry will detain shipments containing cotton and cotton products originating from the Xinjiang Production and Construction Corps (XPCC). CBP’s Office of Trade directed the issuance of a Withhold Release Order (WRO) against cotton products made by the XPCC based on information that reasonably indicates the use of forced labor, including convict labor. The WRO applies to all cotton and cotton products produced by the XPCC and its subordinate and affiliated entities as well as any products that are made in whole or in part with or derived from that cotton, such ...
    12-03-2020, 03:17 AM
  • Staff Reporter 1
    HHS and DOD Award 11.6 Million Dollars Contract to Puritan Medical Products to Boost U.S. Production of Swabs for Cue Health COVID-19 Tests
    by Staff Reporter 1
    HHS and DOD Award $11.6 Million Contract to Puritan Medical Products to Boost U.S. Production of Swabs for Cue Health COVID-19 Tests | site |


    (Information contained in U.S. Department of Health and Human Services press release: November 23, 2020) The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DOD) have jointly awarded an $11.6 million contract to Puritan Medical Products Company, LLC, to expand domestic production capacity of Cue Sample Wands, the nasal swabs used exclusively with the COVID-19 cartridge-based molecular testing system developed and manufactured by Cue Health, Inc. The test generates results in about 20 minutes at the point-of-care (POC). Awarded November 19, the new contract will allow Puritan Medical to expedite upgrades at its Maine facility and increase production capability of Cue’s nasal swabs to 3 million per month by March 2021. These efforts support the federal government’s procurement of 6 millio...
    11-24-2020, 06:31 AM

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