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  • Hampden 9

    Balza Dress in Green and White Stripes

    All items are final sale - no returns or exchanges will be accepted. Sale items are NOT... [More]

    Price: $228.00
  • The Stedfast Christian


    Direct Link


    If no sound, please press HERE

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  • Stream 307A



    Direct Link

  • Truth

    Sanctify them through thy truth: thy word is truth.   (John 17:17 - - in the Holy Bible)
  • Pastor Clarence William Page


    Direct Link
  • Stream 2307-8

    Stream 2307 | Opt 8 |







    ^^^Link^^^


  • Choose Your Subject

  • Stream 173-85



    Mixed Link



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  • More at LTGOF.NET


    There is much more content at LTGOF.NET site.

    Please press here
  • Stream 1606






    Opt 1  |  Opt 2  |  Opt 3  |    More




  • Hurricane Information

  • Tractor

    Tractor Supply
  • SPY ASSOCIATES

    SPY ASSOCIATES
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    Price: $179.99
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  • Horne

    Horne Nelson Bubble Lamps Sale 15% OFF May 3rd - 15th - 300X600.
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    Black Friday 25% Off - Gem And Harmony
  • Hampden 20

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  • Hampdan 29

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  • SpyFinder Pro Hidden Camera Detector

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  • Hampden 25

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  • Hampden 22

    Big Skirt in Maui

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  • Air Quality Conditions in Ann Arbor, MI Zip Code 48104

  • Hampden 27

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  • Hampden 32

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  • Hampden 18

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  • Hampden 11

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  • Webinars Ready




    Webinars Ready


    Special update note:
    It is my understanding that the U.S. Government has addressed or has begun to address some of the issues I raised in the following webinar.
    Pastor Clarence William Page

    Please view our discussion titled "Are Researchers Creating "Humanized Mice"?

    Listening link: http://www.morehere.org/webinars/Researchers Creating Humanized Mice_.mp4

    Press HERE to go to the listening site now.






  • Hampden 15

    Beau Addition in Ivory

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  • Hampden 23

    Bonne Sequin Skirt in Khaki

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  • Hampden 12

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  • Hampden 21

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  • Come

    Come unto me, all ye that labour and are heavy laden, and I will give you rest. (Matthew 11:28 - - - The Holy Bible) * * * * * * * God loves you!!!
  • Believe!



    Direct Link

  • Be Ye Holy

     15  But as he which hath called you is holy, so be ye holy in all manner of conversation;
     16  Because it is written, Be ye holy; for I am holy. (1 Peter 1:15-16 - - - in the Holy Bible)
  • Righteous Judgment

    Judge not according to the appearance, but judge righteous judgment.  (John 7:24 - - in the Holy Bible)
  • Choose Your Subject

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  • Stream 977

               
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  • Almighty God LOVES you!!!

    Almighty God LOVES YOU!!!
  • Visit GloryStar




    North America's Largest Christian Satellite Network
  • Stream 173-89



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  • Hampden 33

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  • ShelterLogic

    Lake Life
  • National Hurricane Center

  • Hampden 41

    Althea Heel in Navy

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  • Hampden 3

    Apex Sandal in Papaya

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    Price: $225.00
  • FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs

    FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance | site |



    (November 06, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information:



    November 06, 2020

    Statement From:
    Director - Center for Drug Evaluation and Research
    Patrizia Cavazzoni M.D.

    Protecting patients from exposure to poor quality compounded drugs is a fundamental part of the U.S. Food and Drug Administration’s drug compounding program, and we are committed to protecting patients. While compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product, these drugs have not been reviewed by the FDA for safety, effectiveness or quality. The FDA through its oversight of compounded drugs strives to help improve the quality of compounded drugs and reduce risk to patients.


    Under federal law, a drug is considered adulterated if it is prepared, packed or held under insanitary conditions that could cause the drug to become contaminated with filth or rendered injurious to health. While some compounders work hard to meet quality standards, too often, FDA investigators continue to observe poor conditions at compounding facilities that impact drug quality and have the potential to harm patients who use the drugs. These insanitary conditions include dirt, mold, insects, trash, peeling paint, unclean exhaust vents and dirty high-efficiency particulate air (HEPA) filters, among many other examples. Numerous compounders have voluntarily recalled drug products intended to be sterile, and also temporarily or permanently stopped sterile operations because of these inspectional observations. The FDA has also taken regulatory and enforcement actions when we observe these insanitary conditions.

    Because of these and other concerning examples we have witnessed, today we’re releasing a final guidance to further our efforts to help compounders identify and prevent insanitary conditions at their facilities. The final guidance provides recent examples of insanitary conditions that we’ve observed at compounding facilities and details corrective actions that facilities should take when they identify these conditions.

    Based on comments to the revised draft guidance, we also added recommendations for compounders to use risk management tools to develop appropriate controls to prevent insanitary conditions at their facilities. Additionally, the guidance addresses the regulatory actions that the FDA may take in response to insanitary conditions. Through our oversight and regulatory actions, we address insanitary conditions at compounders’ facilities across the country. We will continue to take appropriate action to protect patients from poor quality drugs made in facilities that have insanitary conditions. And our collaborative work with states and the Department of Justice remains ongoing.


    Both traditional compounders and outsourcing facilities should take measures to avoid insanitary conditions. We urge compounders to use this valuable resource to better understand insanitary conditions and take necessary actions to avoid such issues for the safety of the patients who receive their drugs.







    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
  • Hampden 5

    Asymmetric Pearl and Turquoise Candy Necklace

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  • Hampden 19

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  • Hampden 2

    Annie Hat in Natural/Black

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    Price: $149.00
  • Weather Info