Drugs

FAERS Public Workshop Report

A 7/17 CDER Workshop, “Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting Systems (FAERS) Using International Council for Harmonization E2B (R3),” laid a foundation for the agency’s transition to FAERS II, described as a different underlying architecture that will incorporate the changes the agency agreed to in ICH E2B (R3).

CDER Office of Surveillance and Epidemiology director Gerald Dal Pan said FDA wishes it could have switched to the new system sooner, rather than being the last large regulatory body to implement R3. He said that in the new system, FAERS is being expanded to accommodate types of reports that have not been traditionally sent to it. While traditionally it has been for adverse events reports for biologics and drugs for approved products and marketed products, he said, it now will incorporate IND safety reports.

Putting the IND reports into FAERS, Dal Pan said, “will allow pre-market reviewers much better and more efficient access to them.”

In addition, generic drug manufacturers will be submitting adverse event reports to FAERS. And there are new requirements for combination product safety reporting.

Dal Pan expressed the hope that the three public meetings the agency is holding will ease the transition when it occurs.

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