Biologics

FDA Eases Blood Donor HIV Recommendations

FDA has published a guidance, Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products, revising the agency’s recommendations for evaluating blood donor eligibility due to human immunodeficiency virus (HIV) using individual risk-based questions. The document says that based on a review of the available science, FDA recommends eliminating the screening questions specific to men who have sex with men and women who have sex with such men. “Instead,” it says, “we recommend assessing donor eligibility using the same individual risk-based questions relevant to HIV risk for every donor regardless of sex or gender.”

FDA also recommends deferring any individual taking medications to treat or prevent HIV, saying that antiretroviral drugs do not fully eliminate the virus from the body and thus donated blood from individuals infected with HIV and taking antiretrovirals could potentially still transmit HIV to a transfusion recipient.

The guidance supersedes a 4/2020 guidance and applies to the collection of blood and blood components, including source plasma.

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

Read more

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