Stories
Slash Boxes
Comments

SoylentNews is people

posted by Fnord666 on Monday May 25 2020, @05:47PM   Printer-friendly
from the demonstrate-that-it-works dept.

US begins crackdown on unvetted virus blood tests:

U.S. regulators are moving ahead with a crackdown on scores of antibody tests for the coronavirus that have not yet been shown to work.

The Food and Drug Administration on Thursday published a list of more than two dozen test makers that have failed to file applications to remain on the market or already pulled their products.

The agency said in a statement that it expects the tests "will not be marketed or distributed." It was unclear if any of the companies would face additional penalties.

Most companies faced a deadline earlier this week to file paperwork demonstrating their tests' performance. Regulators required it after previously allowing tests to launch with minimal oversight, which critics said had created a "Wild West" of unregulated testing.

[...] Under pressure to increase testing options, the FDA in March essentially allowed companies to begin selling antibody tests as long as they notified the agency of their plans and provided disclaimers, including that they were not FDA-approved.

The FDA is now working with the National Institutes of Health and other federal health agencies to vet the accuracy of the tests and determine how they can be used to track and contain the virus.


Original Submission

 
This discussion has been archived. No new comments can be posted.
Display Options Threshold/Breakthrough Mark All as Read Mark All as Unread
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
  • (Score: 2) by PocketSizeSUn on Tuesday May 26 2020, @07:28PM

    by PocketSizeSUn (5340) on Tuesday May 26 2020, @07:28PM (#999341)

    US refused to use the tests being offered by WHO

    Statement distinctly lacking in truthiness
    From this premise the remaining assertions about lack of available tests and testing is similar lacking in well ... any? understanding of epidemiology, testing, contagious diseases ...

    As to your second paragraph .. well that is also misleading.

    https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expedites-review-diagnostic-tests-combat-covid-19 [fda.gov]

    Hmm so not 'fixing' a problem created by 'relaxed rules' is distinctly lacking in truthiness.
    It does not happen often but there are cases where something that requires FDA approval (makes medical claims) is sold w/o approval.
    There is even an FDA process for acquiring such tests/drugs et. al., usually for the purpose of study.

    The FDA eventually finds out, tracks it down, and halts the sale and distribution. Now they have turned their attention to the wide proliferation of Covid-19 tests which have not been approved.

    Again literally everything you stated is either false or disturbingly misleading.

    Starting Score:    1  point
    Karma-Bonus Modifier   +1  

    Total Score:   2