Tag Archives: FDA

Coronavirus Pandemic Forces FDA to Sharply Curtail Drug Company Inspections

Coronavirus Pandemic Forces FDA to Sharply Curtail Drug Company Inspections

Coronavirus Pandemic Forces FDA to Sharply Curtail Drug Company Inspections Coronavirus Pandemic Forces FDA to Sharply Curtail Drug Company Inspections Proponents of remote audits say they can do the same thing virtually. Peter Miller, president of Dynamic Compliance Solutions, of New Jersey, which helps life science companies comply with F.D.A. regulations, says his remote audit kit can do a great …

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Covid Vaccines: Johnson & Johnson’s shot authorized by F.D.A.

Covid Vaccines: Johnson & Johnson's shot authorized by F.D.A.

Covid Vaccines: Johnson & Johnson’s shot authorized by F.D.A. Covid Vaccines: Johnson & Johnson’s shot authorized by F.D.A. WASHINGTON — The Food and Drug Administration on Saturday authorized Johnson & Johnson’s single-shot Covid-19 vaccine for emergency use, beginning the rollout of millions of doses of a third effective vaccine that could reach Americans by early next week. The announcement arrived …

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F.D.A. Expert Panel Endorses Johnson & Johnson’s Vaccine

F.D.A. Expert Panel Endorses Johnson & Johnson’s Vaccine

F.D.A. Expert Panel Endorses Johnson & Johnson’s Vaccine F.D.A. Expert Panel Endorses Johnson & Johnson’s Vaccine Johnson & Johnson’s Covid-19 vaccine was endorsed on Friday by a panel of experts advising the Food and Drug Administration, clearing the last hurdle before a formal authorization expected on Saturday, according to two people familiar with the agency’s plans. The nation’s first shipments …

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F.D.A. Analyses Find Johnson & Johnson Vaccine Works Well

F.D.A. Analyses Find Johnson & Johnson Vaccine Works Well

F.D.A. Analyses Find Johnson & Johnson Vaccine Works Well F.D.A. Analyses Find Johnson & Johnson Vaccine Works Well The one-shot coronavirus vaccine made by Johnson & Johnson provides strong protection against severe disease and death from Covid-19, and may reduce the spread of the virus by vaccinated people, according to new analyses posted online by the Food and Drug Administration …

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Vaccines Adapted for Variants Will Not Need Lengthy Testing, F.D.A. Says

Vaccines Adapted for Variants Will Not Need Lengthy Testing, F.D.A. Says

Vaccines Adapted for Variants Will Not Need Lengthy Testing, F.D.A. Says Vaccines Adapted for Variants Will Not Need Lengthy Testing, F.D.A. Says The Food and Drug Administration said on Monday that vaccine developers would not need to conduct lengthy randomized controlled trials for vaccines that have been adapted to protect against concerning coronavirus variants. The recommendations, which call for small …

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Who Will Be the Next F.D.A. Chief?

Who Will Be the Next F.D.A. Chief?

Who Will Be the Next F.D.A. Chief? Who Will Be the Next F.D.A. Chief? Two leading contenders generate wider debate about the leadership needed to restore morale and scientific integrity to an agency battered by the politicized Trump administration. Source link

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FDA Agrees Moderna Can Increase Vaccine Supply in Each Vial

FDA Agrees Moderna Can Increase Vaccine Supply in Each Vial

FDA Agrees Moderna Can Increase Vaccine Supply in Each Vial FDA Agrees Moderna Can Increase Vaccine Supply in Each Vial WASHINGTON — The Food and Drug Administration has informed the drugmaker Moderna that it can put up to 40 percent more coronavirus vaccine into each of its vials, a simple and potentially rapid way to bolster strained supplies, according to …

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As Millions Get Covid Vaccine Shots, F.D.A. Struggles With Safety Monitoring

As Millions Get Covid Vaccine Shots, F.D.A. Struggles With Safety Monitoring

As Millions Get Covid Vaccine Shots, F.D.A. Struggles With Safety Monitoring As Millions Get Covid Vaccine Shots, F.D.A. Struggles With Safety Monitoring “It’s great for routine stuff, but when it comes to safety surveillance, it’s all about size,” said Dr. Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University, and a former federal vaccine official. “The …

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F.D.A. Approves Monthly Shots to Treat H.I.V.

F.D.A. Approves Monthly Shots to Treat H.I.V.

F.D.A. Approves Monthly Shots to Treat H.I.V. F.D.A. Approves Monthly Shots to Treat H.I.V. It’s what many people with H.I.V. have long awaited: monthly injections to keep the virus in check, instead of the three pills daily they now must take. The Food and Drug Administration on Thursday approved a combination of two monthly shots for treatment of H.I.V. in …

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Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief

Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief

Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief Dr. Stephen M. Hahn, who became commissioner of the Food and Drug Administration just weeks before the coronavirus pandemic began, resigned on Wednesday as the administration of President Biden began. Dr. Janet Woodcock, the longtime head of the F.D.A.’s Center for Drug …

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