Drugs

CDER Urges Drug Makers to Improve Technology

CDER is urging drug manufacturers to “adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective,” which would also help prevent drug shortages. In a 2/1 blog posting by CDER Office of Pharmaceutical Quality director Michael Kopcha, he says the agency has recently established the Emerging Technology Team (ETT) to help firms transition to newer technologies. This specialized group “works directly with industry to help identify and resolve scientific issues for new technologies,” he says. “What makes this approach novel is that this dialog can occur during early technology development prior to the submission of a drug application to the FDA. Such early engagement enables the FDA to proactively identify and address potential roadblocks and helps eliminate potential delay in the adoption of promising new technologies.”

Additionally, Kopcha says the agency recently issued a draft guidance on Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base that provides recommendations for those interested in participating in a program involving chemistry, manufacturing, and controls (CMC) submissions containing emerging manufacturing technology. “Modernizing manufacturing technology may lead to a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the drug products manufactured in any given period of time will provide the expected clinical performance,” the document says. “For example, contemporary aseptic manufacturing facilities that are highly automated and use isolators and other modern separation technologies have the potential to decrease the risk of contamination from the processing line.”

“Expanding this program will not only help to prevent drug shortages,” Kopcha says, “ it will help reinvigorate our country’s pharmaceutical manufacturing sector while fulfilling a critical part of FDA’s mission: ensuring that safe and effective drugs are consistently available to the American public.”

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