Biologics

Covid-19 Convalescent Plasma Emergency IND

CBER says it is possible that convalescent plasma collected from recovered Covid-19 patients could contain antibodies to the SARS-CoV-2 virus and thus be effective against the infection. While clinical trials on such use are being pursued, the Center says in an online post that it is facilitating access to Covid-19 convalescent plasma for use in patients with serious or immediately life-threatening Covid-19 infections through the process of single-patient emergency INDs for individual patients.

The post lists factors that should be considered by healthcare providers interested in the emergency use of investigational Covid-19 convalescent plasma under a single-patient emergency IND.

CBER says that using convalescent plasma has been studied in outbreaks of other respiratory infections and, although promising, is not effective in every disease studied. “It is therefore important to determine, through clinical trials, before routinely administering convalescent plasma to patients with Covid-19 that it is safe and effective to do so,” CBER says. “Investigators wishing to study the use of convalescent plasma are encouraged to submit requests to FDA for investigational use under the traditional IND regulatory pathway.”

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