Drugs

Cancer Groups Offer Oncology Trial Guidance

The American Society of Clinical Oncology and the Friends of Cancer Research have submitted to FDA recommended language for five guidance documents to broaden eligibility criteria for cancer clinical trials. The groups say (includes link to submission package) the recommendations are part of their collaboration to broaden eligibility for participating in clinical trials by addressing minimum age, requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.

“The recommendations aim to maximize the generalizability of clinical trial results while also maintaining the safety of clinical trial participants,” the submission cover letter says. “FDA guidance will assist sponsors in designing more representative trials, and we hope FDA seriously considers adopting the proposed set of guidance documents. We believe that the rationale for excluding patients from eligibility for a cancer clinical trial should be clearly articulated and should be based on the specific therapy under investigation and the study population to help improve trial accrual, ensure optimal patient success, and maximize information learned during the clinical trial.”

The groups say the agency plans to review the recommended language as it finalizes draft guidance documents to release for public comment.

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