Drugs

FDA Supports 21st Century Manufacturing Technologies: Article

An online article written for the Parenteral Drug Association looks at how FDA initiatives are driving 21^st century drug manufacturing technology. The article notes that the Covid-19 pandemic has demonstrated the consequences of inefficient manufacturing and supply chain challenges. It says that advanced manufacturing involves activities that use data-driven science to understand the capabilities of novel technologies.

“The goal is to use the appropriate technology to help improve quality and capacity of the product,” the article says. “Some general examples of these technologies are the application of automation, advanced on-line analytics, or even artificial intelligence.”

The article covers the FDA Emerging Technology Program, 3D Printing as an Example, and From Batch to Continuous. It concludes by describing the work of the Process and Environmental Monitoring Methods working group that is focused on the use and implementation of real-time alternative methods for air and water monitoring.

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