Drugs

HHS Touts Pharmacy on Demand Project

HHS officials say the agency is investing in On Demand Pharmaceuticals’ Pharmacy on Demand modular manufacturing unit to make the U.S. the most competitive nation in the world for drug manufacturing. An agency statement describes an 8/13 visit made by HHS to On Demand Pharmaceuticals’ new centralized production and repackaging manufacturing facility in Rockville, MD. The statement says the facility produces active pharmaceutical ingredients for medicines of critical importance to the U.S. healthcare system.

The officials virtually toured the pharmacy on demand unit that the statement says leverages the latest artificial intelligence and machine learning techniques and can be quickly customized to produce any finished dosage form whenever and wherever needed. The unit is currently at the Northern Mississippi Medical Center to produce medicines that are in shortage in real-time, HHS says.

“This collaboration not only underscores the strategic importance of bolstering domestic production of finished drugs but also sets the stage for transforming how medicines are made and delivered in this great country of ours,” said HHS Administration for Strategic Preparedness principal deputy assistant secretary John Knox. “Having the added flexibility and capability to deploy a network of modular medicine production facilities to produce drugs wherever needed is key to mitigating drug shortages and supporting disaster operations, especially when responding to unexpected disease outbreak or to hurricanes, wildfires, or other natural disasters that often disrupt regular distribution channels or cause sudden shutdowns to pharmaceutical manufacturing plants.”

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