Drugs

CDER Ombudsman Total Contacts Down

The CDER Ombudsman 2017 annual report shows a 28% decrease in the number of stakeholder contacts from 289 in 2016 to 207 in 2017. “Based upon percentage decreases from 2016 to 2017,” the report says, “the two demographic categories with the most significant drops were the number of whistleblowers, which went from 21 to 10, and investors, from 16 to 2.”

Of the 207 total contacts in 2017, 157 were from external parties, primarily commercial firms (89), law firms (32), and whistleblowers (10). The remaining 50 contacts were from staff in FDA Centers.

The most common contact topics from external parties were dispute resolution assistance, general inquiries, decision or response delays, limited or no access to drugs due to an FDA regulatory action, communication issues, complaints that CDER wasn’t following regulations or proper procedures, complaints about a CDER decision or action, and industry whistleblower.

In most cases, the report says, agency employees asked for advice about a difficult situation either an internal issue or one involving an external constituent.

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