FDA

Health Experts to F.D.A.: Make Your Vaccine Deliberations Public

A coalition of leading public health experts urged the Food and Drug Administration on Wednesday night to conduct full safety and efficacy reviews of potential coronavirus vaccines before making the products widely available to the public.

In a letter signed by nearly 400 experts in infectious diseases, vaccines and other medical specialties, the group called on Dr. Stephen Hahn, the F.D.A. commissioner, to be forthcoming about the agency’s deliberations over whether to approve any new vaccine, in order to gain the public’s trust.

“We must be able to explain to the public what we know and what we don’t know about these vaccines,” noted the letter, which was organized by the nonprofit Center for Science in the Public Interest. “For that to happen, we must be able to witness a transparent and rigorous F.D.A. approval process that is devoid of political considerations.”

More than 30 experimental coronavirus vaccines are in

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FDA Revokes Emergency Coronavirus Use of Malaria Drugs

The Food and Drug Administration said on Monday that it was revoking emergency authorization of two malaria drugs to treat Covid-19 in hospitalized patients, saying that they are “unlikely to be effective” and could carry potential risks.

The drugs, hydroxychloroquine and chloroquine, were heavily promoted by President Trump after a handful of small, poorly controlled studies suggested that they could work against the disease caused by the coronavirus. Mr. Trump said he took hydroxychloroquine after he had been exposed to two people who tested positive for the coronavirus.

The agency said that after reviewing some data, it determined that the drugs, particularly hydroxychloroquine, did not demonstrate potential benefits that outweighed their risks. Earlier this spring, the F.D.A. had also issued a warning that the drugs could cause dangerous heart arrhythmias in Covid-19 patients.

The review that led to the revocation found more than 100 cases of serious heart disorders in

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F.D.A. Approves First Antigen Test for Detecting the Coronavirus

Unlike commonly available coronavirus tests that use polymerase chain reaction, or PCR, antigen diagnostics work by quickly detecting fragments of virus in a sample. The newly approved Quidel test will rely on specimens collected from nasal swabs, according to the F.D.A., and they can only be processed by the company’s lab instruments.

“Diagnostic testing is one of the pillars of our nation’s response to Covid-19, and the F.D.A. continues to take actions to help make these critical products available,” the agency said in a statement on Saturday. “One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes.” The F.D.A. said it expects to grant emergency clearance for other antigen tests in the near future.

A shortage of coronavirus tests in the United States has hampered efforts to contain the pandemic, and has limited the capabilities of states seeking to

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F.D.A. Paves Way for Home Testing of Coronavirus

In a move that could significantly expand the nation’s testing capacity, the Food and Drug Administration has posted new guidelines that could pave the way for millions of people to test themselves for the coronavirus at home.

The guidelines allow companies to develop and market testing kits with the tools to swab their noses and mail the specimens to any lab in the country.

Access to tests has been improving, but nationwide testing shortages continue to hamper the ability of health authorities to identify and isolate people who are infected.

The F.D.A. said it hoped the new guidelines, posted on its site on Wednesday

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