Drugs

OCE Highlights Efforts During Covid Year in 2020

FDA’s Oncology Center of Excellence (OCE) annual report for 2020 describes OCE’s work on behalf of cancer patients affected by the Covid-19 pandemic. “OCE participated in writing a guidance emphasizing the flexibility that FDA would exercise with regard to conduct of clinical trials with decentralized trial procedures aimed at patient safety,” the report says. “Patients often cannot go back to major cancer centers, and some of the testing and doctor visits can be conducted in communities nearer to patients’ homes, so the guidance allows for that. OCE went on to issue over a dozen guidances in 2020 on many aspects of oncology drug development.”

Other highlights of the report:

the approval in 2020 of 40 new indications and 19 new molecular entities for oncology indications;
the shift to online listening sessions from in-person workshops;
initiation of projects to increase minority and geriatric patient enrollment in clinical trials; and
initiation of a project to incorporate symptomatic side effect assessment by the patient, rather than the medical professional, to inform the tolerability of cancer therapies.

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