Drugs

Praise for Graft-Versus-Host Drug Guidance

The American Society of Hematology says it commends FDA for releasing its draft guidance on developing products to prevent or treat graft-versus-host disease (GVHD). The society comment letter says investigators and hematologists conducting stem cell transplants can benefit from the guidance on acute and chronic GVHD. “To ensure that this guidance serves patients effectively and is comprehensive, it will be helpful for the agency to provide guidance on the use of composite endpoints…,” the letter says. “These endpoints are already being used in prospective studies and including them in this guidance can help sponsors feel comfortable incorporating them into future studies.”

The NIH Consensus Project on clinical trials in chronic GVHD says FDA “has done an outstanding job in drafting this guidance, which will be of great help to sponsors and investigators working on products for prevention or treatment of GVHD.”

In its response, the American Society for Transplantation and Cellular Therapy says it applauds FDA for assembling the guidance.

All three commenters provide specific line-by-line comments and recommendations, as does Sanofi.

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