Drugs

FDA, EMA Form Joint Working Group on Patient Engagement

FDA and the European Medicines Agency (EMA) have expanded their international collaboration by setting up a new forum or “cluster” on patient engagement. The working group will teleconference several times a year to share experiences and best practices on the way the two agencies involve patients in drug development, evaluation and post-approval activities. Areas of discussion will include the processes for selecting and preparing patients to take part in the agencies’ activities, how to ensure that patients are independent and representative, and how to report on the impact of patient involvement.

“Our aim as regulators is to make sure that patients have access to safe and effective medicines that improve their lives,” an EMA release says. “It is important to engage to be able to fully understand their needs and priorities and make their voice heard along a medicine’s lifecycle. Many of the challenges and benefits of working with patients are similar for both regulators.”

Clusters established by EMA and FDA are intended to focus on specific topic areas where the parties involved could benefit from an intensified exchange of information and strengthened collaboration. Currently existing clusters discuss issues related to biosimilars, medicines to treat cancer, orphan medicines, medicines for children, and pharmacovigilance, among other topics, EMA says.

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