Drugs

Questions on Oncologic Investigational Agent Guidance

The National Cancer Institute says it has four concerns about an FDA guidance that requires studies of oncologic investigational agents to enroll additional patients on multiple dose levels to assess activity for dose optimization, before the therapy’s clinical effectiveness has been established and before the tolerability of therapy has been determined to be unacceptable. The comment letter says the concerns are:

most agents in Phase 1 studies will not be developed into marketable agents and will not be shown to provide benefits for patients;
most investigational drugs that are developed into marketed agents are tolerable at the dose used in Phase 3 studies and the guidance focuses on a small minority of approved oncologic agents;
the guidance does not contain clear criteria for defining tolerability and does not describe how the precision of its measure can be determined; and
the supposition that a biologically effective dose … is related to the clinical effectiveness of an investigational agent is pure conjecture for most agents.

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