Drugs

CDER Holding Preventable Harm Symposium

CDER’s Professional Affairs and Stakeholder Engagement staff is hosting a 6/15 public meeting called “Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting.” CDER director of professional affairs and stakeholder engagement John Whyte says in an FDA Voice blog post that those attending the symposium “will consider situations such as the use of inappropriate medications in certain age groups, the use of drugs that interact with one another, and unintended exposures of dangerous medications to children.”

The meeting is to include representatives from several federal agencies, state regulatory bodies, healthcare insurers, and patient advocacy organizations.

“During this symposium, we want to generate ideas for specific solutions to reduce preventable harm and discuss how to evaluate the ideas’ effectiveness,” Whyte writes. “These new ideas for future research can be funded by grants from FDA’s Safe Use Initiative. A variety of important research projects have been completed and FDA offers new opportunities on an ongoing basis.”

Whyte says that reducing preventable harm from medications is a big part of FDA’s mission that requires teamwork across all of healthcare and the medication manufacturing, distribution, and delivery system.

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