Drugs

Efforts to Make FDA Approval Packages More Helpful

OpenTrialsFDA says it is working to make FDA drug approval packages (DAPs) from the agency Web site easily searchable and accessible and to link them to documents and data related to clinical trials. In a description of their work, the app developers say that DAPs are published at an agency data portal known as Drugs@FDA. “These documents contain detailed information about the methods and results of clinical trials, and are unbiased, compared to reports of clinical trials in academic journals,” the post says. “This is because FDA reviewers require adherence to the outcomes and analytic methods pre-specified in the original trial protocols so, in contrast to most journal editors, they are unforgiving of practices such as post hoc switching of outcomes and changes to the planned statistical analyses. These review packages also often report on clinical trials that have never been published.”

Despite their high value, the developers say, the DAPs are notoriously difficult to access, aggregate, and search. The agency Web site is not easy to navigate, they say, and much of the information is in PDFs or non-searchable image files for older drugs. As a consequence, they are rarely used by clinicians and researchers. “OpenTrialsFDA will work on improving this situation,” the post says, “so that valuable information that is currently hidden away can be discovered, presented, and used to properly inform evidence-based treatment decisions.”

The developers intend to create a new OpenTrialsFDA interface and also will integrate the information into the OpenTrials database, so that for any trial for which a match exists, users can see the corresponding FDA data.

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