Drugs

CTTI Recommendations on Pediatric Antibacterial Development

The Clinical Trials Transformation Initiative (CTTI) has released new recommendations to streamline and improve pediatric trials in antibacterial drug development. Regarding pediatric drug development planning, CTTI recommends that sponsors engage with FDA to begin pediatric studies as early in drug development as possible to ensure a clear understanding of FDA requirements. Also, it says sponsors should consider doing this earlier in drug development than is current practice (for example, while Phase 2 adult trials are underway). And sponsors should consider initiating pediatric pharmacokinetic studies, especially in the older cohort of children, concurrently with adult Phase 3 trials when appropriate.

On trial protocol design and development, CTTI recommends that sponsors minimize the burden of participation for patients, their caregivers and study sites. “During the design and development of the protocol, obtain the input of stakeholders who will be affected by implementation of the trial(e.g., nurses, study coordinators, parents, patients, clinicians, site investigators),” it says. Also, sponsors should identify barriers that will affect trial efficiency and enrollment, including visit windows, invasive testing, endpoint timing, and length of follow-up.

Additionally, CTTI says sponsors should “streamline data collection to include only that which is relevant to the goals of the trial.” It says data collection should be focused on pre-specified, relevant outcomes, which should be primarily safety and PK, with efficacy endpoints as appropriate. “When efficacy in children can be extrapolated based on the demonstration of efficacy in adults, collection of efficacy data can be streamlined in the safety and PK studies,” CTTI 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