Biologics

Blood Donor Screening in an Ebola Outbreak

FDA has published a guidance, Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral, and Blood Product Management in Response to an Ebola Disease Outbreak, notifying blood collection establishments of the agency’s determination of Ebola to be a transfusion-transmitted infection. The document includes the agency’s recommendations for assessing blood donor eligibility, donor deferral, and blood product management in the event of an Ebola disease outbreak in at least one country.

The guidance was developed in response to the 2014 Ebola outbreak in West Africa, FDA says, but it expects the recommendations to apply to all Orthoebolaviruses that cause Ebola in humans should an Ebola disease outbreak occur.

The guidance updates a 1/2017 guidance that finalized a 12/2015 draft. FDA says the updates involve minor changes.

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