Biologics

Covid-19 Convalescent Plasma Guidance

FDA has published a guidance, Recommendations for Investigational and Licensed Covid-19 Convalescent Plasma, with recommendations to blood establishments for submitting a BLA for the manufacture of Covid-19 convalescent plasma for transfusion intended to treat patients with immunosuppressive disease or receiving either outpatient or inpatient immunosuppressive treatment. The document also has recommendations for INDs for investigational Covid-19 convalescent plasma for transfusion.

The guidance is being implemented without prior public comment, FDA says, because the agency recognizes SARS-CoV-2 continues to circulate and Covid-19 remains a serious health risk, especially for patients with immunosuppressive disease or receiving immunosuppressive therapy.

FDA says the recommendations for INDs supersede the recommendations on that issue in a 10/2023 guidance. All the other recommendations in that guidance remain in effect. The agency says it intends to withdraw the 10/2023 guidance when Covid-19 convalescent plasma is no longer authorized for emergency use.

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