Drugs

Woodcock and Colleagues Defend ‘Integrated Reviews’

In a letter to JAMA Internal Medicine published 7/27, CDER director Janet Woodcock and two of her Center colleagues defend the agency’s use of so-called integrated reviews from concerns that they won’t meet the agency’s goals and may introduce new problems. With the modernized reviews, FDA intends to enhance the clarity of premarketing benefit/risk assessments and improve communication concerning approval decisions, they write.

Woodcock describes the integrated review’s three-part structure as an executive summary, including discussion of benefit versus risk and conclusions leading to regulatory action; an interdisciplinary assessment; and appendices, including discipline-specific reviews.

“Integrated reviews are the product of a multidisciplinary team assessment process,” the letter says. “The executive summary represents, with one voice, FDA’s conclusions regarding key scientific and regulatory issues related to the application. The assessment process includes collaborative discussions and resolution of important issues pertinent to benefit/risk assessments that span multiple disciplines. This interdisciplinary approach results in clarity of decision-making and provides a synthesis of the team’s deliberations on the key issues in the main body of the text, making the content more comprehensible to clinicians, patients, and patient advocacy groups.”

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

Read more

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