Drugs

FDA Staff Take Aim on ICH Model-Informed Development

FDA says staff from CDER and CBER will be part of a new International Council on Harmonization (ICH) formal expert working group to develop the guideline (ICH M15), which will outline principles for Model-Informed Drug Development (MIDD). This comes on the heels of ICH’s 11/2022 finalized concept paper and business plan on MIDD.

FDA says MIDD is an umbrella term covers the “integration and application of statistical, biological, and pharmacological data in support of clinical trial design and quantitative decision making, and includes, but is not limited to, quantitative systems pharmacology, physiologically based pharmacokinetic analyses, dose/exposure-response analyses, and disease progression approaches. MIDD can help to conserve resources for industry, aid regulators in limiting human exposure and enhancing regulatory review, and potentially reduce time for approval and availability of new medicines globally as well as informing their better use.”

However, FDA says, there is also a “lack of common documentation standards, model assessment expectations, and understanding of concepts/principles that hinders the assessment of the quality of the data used and the robustness of the analysis, potentially limiting the modelling impact and credibility with respect to its intended applications.”

The recently reauthorized drug user fee agreement includes an agency commitment to advancing modern approaches to improve the efficiency of the drug development and review process, such as MIDD. The agency says it intends to build on a MIDD paired meeting pilot by continuing to advance and integrate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources in drug development and regulatory reviews.

User fee program updates to the MIDD paired meeting program include the total number of granted submissions per quarter, meeting request submission due date, the timeline for meeting background package submissions and timing and scheduling of a follow-up meeting.

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