Biologics

New HIV Blood Donor Guidance

FDA has issued a guidance, Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products, with the agency’s revised donor deferral recommendations for individuals with increased risk of transmitting HIV infections. The guidance says FDA also recommends that establishments that collect blood or blood components make corresponding revisions to their donor educational materials, donor history questionnaires and accompanying materials, along with revisions to the donor requalification and product management procedures.

The revision updates a 1992 guidance and changes the agency recommendations from the indefinite deferral for men who have sex with other men (MSM), to a 12-month blood donor deferral since the last MSM contact. “For other behavioral deferrals such as commercial sex workers and injection drug use,” the agency says, “insufficient data are available to support a change to the existing deferral recommendations at this time.”

FDA also issued a questions-and-answers document on the revised guidance. “FDA expects that the changes made to the recommendations will maintain or improve blood safety with respect to HIV,” that document says. “The change with respect to MSM reflects current scientific evidence, and better aligns the deferral period with the deferral period for other men and women at an increased risk for HIV infection…. To help ensure the continued high level of safety of the blood supply, FDA is implementing a Transfusion Transmissible Infections Monitoring System [that] will provide critical information, along with new and emerging scientific evidence, to help inform future actions that FDA may take on blood donor policies. The system will monitor a majority of the blood collected in the U.S. for a number of different transfusion-transmitted viral infections, including HIV.”

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