Drugs

Modeling Tools to Aid Generic Drug Development

Quantitative methods and modeling (QMM) covers a broad spectrum of tools that can be used in modernizing generic drug development, says FDA in an online Regulatory Science Impact Story. The post says that in both new and generic drug development, mathematical models can be thought of as knowledge management systems that integrate scientific understanding and existing data about drug products.

“For both new and generic drugs,” the article says, “QMM can accelerate product development and regulatory assessment. The huge volume of generic drug applications especially translates into numerous opportunities for use of QMM. The Office of Generic Drugs is currently taking advantage of QMM and is deploying information to industry on best practices for using QMM to modernize generic drug development. “

FDA says the next step for QMM can be to use model-integrated evidence that provides pivotal information for generic drug approval or, in combination with relevant in vitro bioequivalence assessment, serve as an alternative to conducting costly, time-consuming, and less sensitive in vivo studies in appropriate cases.

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