Biologics

FDA Monitoring Virus Variants

FDA is continuing to closely monitor the various identified variants of the virus that causes Covid-19 and also monitoring for emerging variants, according to a series of 1/25 Tweets by FDA acting commissioner Janet Woodcock.

Woodcock says the agency “will continue to factor in newly emerging information in light of our role in regulating diagnostics, therapeutics, and vaccines to fight Covid-19.”

She says FDA is assessing the impact of new virus strains on authorized products and is working with medical product sponsors to provide information on evaluating any potential impact that they or any other variants have on product effectiveness.

“At this time,” Woodcock states, “available information suggests that currently authorized vaccines remain effective in protecting the American public against current strains of Covid-19.” She says the agency is already thinking about developing a potential pathway if changes need to be made to authorized Covid-19 vaccines or other products based on information on emerging variants.

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