Drugs

CDER, CBER Accept 1st ISTAND Submission

CDER and CBER have accepted the first submission for the Innovative Science and Technology Approaches for New Drugs pilot program for developing drug development tools (DDTs). An FDA post says the first accepted letter of intent submission is for a tool that proposes to evaluate off-target protein binding for a variety of biotherapeutic modalities, potentially reducing or eliminating the need to conduct some of the more standard nonclinical toxicology tests.

“The tool’s developers hope it will improve the accuracy, sensitivity, and overall utility of specificity testing of biotherapeutics to support INDs,” the post says.

The Centers say acceptance of the letter of intent is the first step in a three-step process in the DDT qualification program. It is based on several factors, including the scientific merit of the submission, the ability of the DDT to address a specified drug development need, the availability of information and resources that support the proposed qualification effort, and a demonstration that the DDT is feasible and practical within the proposed context of use.

FDA says it will now work with the applicant to provide feedback on the next qualification step — a qualification plan.

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