Drugs

Key Provisions of ClinicalTrials.gov Final Rule

Attorneys Gail Javitt and Jae Kim (DLA Piper) say the HHS final rule on expansion of the national clinical trials database (ClinicalTrials.gov) runs 177 pages and aims to improve public access to information about specified clinical trials involving FDA-regulated products. “The final rule both implements and elaborates on the requirements of the 2007 FDA Amendments Act and provides a specific deadline by which ‘responsible parties’ (clinical trial sponsors and investigators) must come into compliance,” the attorneys write. Responsible parties are required to submit additional information when registering, update registration within specified timelines in response to new information, and report on a wider range of adverse events, the online post says. The rule also expands the clinical trial categories for which results must be submitted and specifies penalties for non-compliance, including civil and criminal enforcement action by FDA.

Key clarifications and changes in the final rule are highlighted by Javitt and Kim in a chart.

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