Biologics

Tighter Covid Vaccine Approval Standards Coming: Report

FDA is expected to issue a guidance later this week laying out tougher new standards for emergency authorization of a Covid-19 vaccine. The Washington Post says the new standards “will make it exceedingly difficult for any vaccine to be cleared before Election Day.”

The Post article says the new guidance will be issued “to boost transparency and public trust as [FDA] approaches the momentous decision of whether a prospective vaccine is safe and effective.”

Under the new guidance, the agency reportedly would ask manufacturers seeking an emergency authorization to follow participants in late-stage clinical trials for a median of at least two months starting after they receive a second vaccine shot. And the agency reportedly will also look for at least five severe cases of Covid-19 in the placebo group for each trial, as well as some cases of the disease in older people.

“These standards, plus the time it will take companies to prepare their applications and the agency to review the data, make it highly improbable any vaccine will be authorized before the election,” the article says.

An FDA spokesperson declined to comment to the Post on its report, which was based on information from two individuals who are familiar with the situation and asked to comment anonymously.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome