Drugs

FDA Wants Integrated Drug Review Feedback

FDA is asking users of the NDA integrated review format that the agency started using several years ago to provide feedback on questions involving its usefulness. Attorney Deborah Livornese (Hyman, Phelps & McNamara) writes in a Pharmaceutical Online guest column that there are upsides and downsides to producing a leaner integrated review.

“The appeal of distilling the extensive process that goes into the decision to approve an application into a single package is easy to see, and some may be interested in only the ultimate distillation — an approval is issued or not,” she writes. “As frequent consumers of both the old-style Summary Basis of Approval that includes the individual detailed discipline reviews and the new leaner Integrated Assessments, however, we have found the summary nature of the Integrated Assessments to be lacking information that can be critically important in identifying and understanding how resolution was reached on issues identified in the review.”

Livornese points out that those reading an integrated review can’t always identify the opinions of individual CDER medical reviewers. “Those of us seeking to learn how FDA may approach a similar issue in another context want to understand what the differences of opinion were,” she explains…. “Another potential problem with an integrated review is that we can never know what information was eliminated from the individual reviews…. Fully understanding FDA’s thought process and the basis of its conclusions is of particular importance to those who seek to understand how FDA may view the issue in other situations.”

The article lists some of the specific questions to which FDA is seeking responses.

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