Drugs

FDA Proposes More Comprehensive IND Reports

FDA is issuing a proposed rule to replace the current investigational new drug (IND) annual reporting requirement with a new FDA Development Safety Update Report (DSUR). The proposal says the agency currently requires sponsors to submit an annual report with information about each ongoing study related to the IND, and those studies completed in the previous year.

The proposed regulation would require sponsors to submit a more comprehensive and informative report. It would ask for an overall safety analysis and a summary of cumulative safety information, among other requirements. FDA says the changes would help FDA and sponsors understand the safety profile of the investigational drug and, as appropriate, take actions to help protect research study participants.

FDA says the proposed DSUR would be more consistent with the annual safety reporting requirements in other countries and regions as the format and content are similar to that of the report supported by the International Council for Harmonization.

The uniformity would make the reporting process more efficient for sponsors, who could submit similar reports to FDA and regulatory authorities in the European Union and other countries or regions, FDA says.

The agency will receive comments on the proposal for 90 days following the 12/9 publication in the Federal Register.

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