Drugs

2007 FDA Law Brought Better Trial Reporting: Study

A new study has concluded that the FDA Amendments Act (FDAAA) of 2007 has led to more clinical trials being registered and resulted reported on ClinicalTrials.gov. The study, published in Trials Journal, examined trials that supported FDA approval of new drugs for neuropsychiatric indications, found that “reporting results on ClinicalTrials.gov were significantly higher and publication bias was significantly lower after the passage of the FDAAA in 2007, suggesting that the FDAAA likely contributed to the reduction of selective registration and results reporting and to mitigating publication bias. These findings have important implications for understanding the potential impact of the FDAAA, along with other initiatives that may have improved research reporting, and for developing future strategies to improve selective publication and outcome reporting more broadly.”

Before FDAAA, the authors said that among 72 positive trials, none were unpublished or were published with a misleading interpretation. “In contrast, among 29 non-positive trials, 10 were not published and seven were published with misleading interpretations,” they wrote. “Post-FDAAA, among 35 positive trials, again none were unpublished and none were published with a misleading interpretation. In addition, among six non-positive trials, none were unpublished and one was published with a misleading interpretation.”

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