Drugs

FDA Looking for Drug Quality Metrics

FDA plans to request data on pharmaceutical quality metrics and has proposed guidance on data collection and submission, according to the Deloitte Life Sciences Regulatory Outlook for 2017. The document says the proposed guidance would change how FDA schedules its inspections, helping to promote modernization of the drug industry and prompting companies to use data analysis to drive process improvements.

“Pharmaceutical companies should conduct an assessment of their existing systems and processes to ensure they are ready to comply with FDA’s requirements,” the report says. It suggests that areas to address include people, process, and technology.

Deloitte sees the possibility of more challenges to FDA’s position on off-label promotion due to recent court decisions favoring manufacturers. It says the decisions also could make companies more willing to take on the risks of producing promotional materials once considered off-label. And, it says, they could expand companies’ ability to user medical and clinical information that isn’t part of a product’s approved indication. “This has the potential to benefit patients and healthcare providers by bringing additional safety and efficacy information to their attention, leading to better use of prescribed therapies,” Deloitte says.

Looking at medical device cybersecurity, the company says that with the increased risk of cybersecurity attacks as medical devices are increasingly interconnected, “manufacturers have an opportunity to develop efficient security processes that align with” a recent agency guidance. It says this would enable them to address security issues early in the design phase and get to market more quickly than companies that retroactively address security. “In addition,” it says, “having a robust product security organization that aligns with regulatory guidance is a valuable differentiator that could lead to increased sales and an improved reputation.”

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