Drugs

FDA Funding Opioid Prescribing Study

FDA commissioner Scott Gottlieb says the agency has contracted with the National Academies of Sciences, Engineering, and Medicine to help advance development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. “The primary scope of this work is to understand what evidence is needed to ensure that all current and future clinical practice guidelines for opioid analgesic prescribing are sufficient, and what research is needed to generate that evidence in a practical and feasible manner,” Gottlieb says in a statement.

The work will begin with an identification and prioritization of procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed and where evidence-based clinical practice guidelines would help inform prescribing practices, the statement says. As part of its work, the contractor also will scan the landscape of existing opioid analgesic prescribing guidelines, examine how they were developed and any potential gaps in evidence for those guidelines, as well as outline the research needed to generate that evidence. The National Academies also will hold a series of meetings and public workshops to engage a broad range of stakeholders who can contribute expert knowledge on existing guidelines and on emerging evidence or specific policy issues related to the development and availability of opioid analgesic prescribing guidelines based on their specialties.

“We’re optimistic that this new effort will result in new, data-driven guidelines from medical professional societies that can be easily accessible to prescribers (and possibly inform product labeling),” Gottlieb says. “These evidence-based guidelines can help ensure that opioid analgesic prescribing more closely comports with clinical need. Our hope is that these evidence-based guidelines can help decrease unnecessary and/or inappropriate exposure to opioids and the rate of new addiction, while importantly ensuring that patients with a true clinical need are getting thoughtful, careful, and tailored approaches to treatment.”

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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