Drugs

CDER Statisticians Tout Flexible Trial Designs

CDER statistical researchers say they are promoting and developing innovative clinical trial designs to meet the challenges of precision medicine. In an online research post, the statisticians describe work they undertook a few years ago during the Ebola outbreak to evaluate new treatments for the deadly viral disease. They then go on to discuss other adaptive trial designs that can help develop new treatments.

“We need novel approaches to trial design to address challenges posed by emerging infectious diseases, rare diseases, and new cancer subtypes defined by genetic criteria,” the post says. “By designing trials with adaptive features tailored to specific situations and needs, CDER statisticians are helping to make clinical evaluation of new treatments for these diseases more efficient and informative.”

The post says the examples it cites show that CDER researchers “are committed to fulfilling the goals of the 21^st Century Cures Act of 2016, which directs FDA to ‘assist sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs and biological products in order to facilitate more efficient product development.’”

CDER says it also is developing guidance for sponsors on using complex innovative designs, facilitating exchanges within the scientific community on issues pertaining to trial design and trial simulations, and providing statistical expertise to sponsors at critical stages of their drug development programs.

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