Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as ...

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Trump: US funding freeze to WHO could be permanent - Politico

www.politico.com › news › 2020/05/19 › trump-world...

4 hours ago - President Donald Trump threatened to permanently end funding to the World Health Organization and pull out of the international body altogether in a letter ...

Trump threatens to halt WHO funding, review U.S. ... - Reuters

www.reuters.com › us-health-coronavirus-trump-who

14 hours ago - U.S. President Donald Trump threatened on Monday to permanently halt funding for the World Health Organization (WHO) if it did not commit to improvements ...

FDA authorizes infusion pumps' emergency COVID-19 use ...

FDA authorizes infusion pumps' emergency COVID-19 use ...

www.aha.org › news › headline › 2020-05-15-fda-auth...

4 days ago - The guidance, released yesterday, clarifies that intended-sterile drugs can be compounded in segregated compounding areas that are not within cleanrooms, ...

Utah embraced an unproven Covid-19 drug, then raced to ...

Utah embraced an unproven Covid-19 drug, then raced to ...

www.statnews.com › 2020/05/18 › utah-hydroxychloro...

1 day ago - The saga of the drugs' rise and fall in Utah provides a case study of what ... then, if positive, to treatment with compounded hydroxychloroquine or chloroquine.

Meet the big pharma vet in charge of Trump's vaccine strategy ...

Meet the big pharma vet in charge of Trump's vaccine strategy ...

www.politico.com › politico-pulse › 2020/05/14 › meet...

5 days ago - Those are “three of the worst deals in drug industry history,” one pharma industry ... Compounded drugs are produced outside of normal manufacturing facilities, ...

With drugmakers clamoring, FDA looks to restart facility ...

With drugmakers clamoring, FDA looks to restart facility ...

www.fiercepharma.com › manufacturing › fda-looks-to...

5 days ago - The FDA halted most on-site inspections of foreign and domestic drug ... RELATED: Eyeing COVID-19 shortages, FDA unleashes compounded drugs to treat ..

Compounders 'Gravely Concerned' By MOU's 5% Out-Of-State ...

Compounders 'Gravely Concerned' By MOU's 5% Out-Of-State ...

insidehealthpolicy.com › daily-news › compounders-‘g...

4 days ago - ... on interstate distribution of drugs by pharmacy compounders that gives state ... be notified when more than 50% of a compounded drug is sold out-of-state.

New Indictment shows why employment status of compounding employees may matter....employees vs. 1099 contractors

"The marketers were falsely made to appear that they were “bona fide employees” of Xpress Compounding, but they were paid as 1099 contractors by Rxpress Pharmacy, the superseding indictment alleges."

See https://www.dallasnews.com/news/crime/2020/05/15/pharmacy-owners-marketers-charged-in-alleged-14-million-dallas-area-kickback-scheme/

Pharmacy owners, marketers charged in alleged $14 million Dallas-area kickback scheme An updated indictment alleges the men conspired to defraud the U.S. through bribes and kickbacks for the referral of TRICARE and Labor Department beneficiaries.

https://www.dallasnews.com/news/crime/2020/05/15/pharmacy-owners-marketers-charged-in-alleged-14-million-dallas-area-kickback-scheme/

Compounding Pharmacies -- Are Users of Finasteride for Hair ...

www.jdsupra.com › legalnews › compounding-pharma...

5 days ago - It is alleged that the adulterated finasteride combination hair-growth drugs marketed as FinPlus may have been contaminated with minoxidil, another drug that is ..