Drugs

Stakeholder Suggestions for Upcoming Disease Progression Workshop

The Biotechnology Innovation Organization (BIO) says it encourages FDA to include case study examples in an upcoming public workshop on best practices for the development and application of disease progression models. In a comment letter, BIO says its members are willing to offer case study examples for inclusion in meeting agenda topics. The association also asks FDA to develop hypothetical case examples based on agency experience that illustrate key issues and can generate discussion on how obstacles may be overcome. It also recommends additional topics to be considered for the agenda.

In its response, Novartis provides a technical discussion of the three questions FDA posed in soliciting public comment on the workshop — what to model, how to model, and questions on specific modeling.

The Critical Path Institute says that several factors should be considered in articulating a fit-for-purpose context for using drug progression models in drug development. The factors it suggests are (1) the intended application of the disease progression model in a specific stage of drug development; (2) a clinically relevant outcome to describe disease progression; (3) the definition of the target population; (4) detailed description of data sources, and (5) clinically relevant sources of variability to account for.

Finally, Genentech says it hopes the workshop will be the first of many such public discussions on the topic. “We request FDA to dedicate time during the workshop to consider how sponsors, FDA, and other relevant stakeholders (e.g., academics, other health authorities) can continue engaging to share knowledge, resolve challenges, and develop solutions that are applicable and acceptable globally,” it says.

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