Drugs

Industry MIDD Paired Meeting Program Benefits Cited

Drug company representatives say their experience with the FDA MIDD (Model-Informed Drug Development) paired meeting program has been strongly favorable. “The companies have recognized savings in resources, achieved alignment with FDA on developmental strategies, and gained clarity on important aspects of programs and product characteristics,” an open-source report in Clinical Pharmacology and Therapeutics says.

The report is based on a survey of participating companies conducted by the International Consortium for Innovation and Quality in Pharmaceutical Development.

“The totality of evidence on the value of this program demonstrates a definite benefit to patients, the medical community, and pharmaceutical companies,” the report says. “Hence, the permanent adoption and expansion of these meetings and their principles is strongly encouraged.”

The main goals of the program are cited as (1) providing an opportunity for drug developers and FDA to discuss the application of MIDD approaches to the development and regulatory evaluation of medical products, and (2) providing advice about how particular MIDD approaches can be used in a specific drug development program.

Since the program’s inception in 2018 through the first quarter of 2021, the report says, FDA has received 34 meeting requests and granted 30 of them. There have been projects at every stage of development and spanning a large number of therapeutic areas.

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

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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