FDA Policy/General

OPDP Looking at Medical Conference Drug Promotion

The CDER Office of Prescription Drug Promotion (OPDP) is planning to question healthcare providers about their view of prescription drug promotion in exhibit halls at medical conferences. A Federal Register notice says the research will look specifically at how elements of pharmaceutical booths in medical conference exhibit halls affect healthcare provider attendees’ perceptions of the drugs promoted at the booths.

Providers will be asked general questions about their conference attendance, OPDP says, and then more detailed questions about interactions in the exhibit halls.

“A primary reason that physicians and other medical professionals report visiting specific exhibitors at conferences is to obtain product information and it is important that the information provided by exhibitors to healthcare professionals regarding the risks and efficacy of prescription medications not be misleading,” OPDP says. “Thus, investigating the impact of pharmaceutical booth promotions among medical conference attendees has valuable practical implications for the public health.”

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