Drugs

FDA Republishes OTC Monograph Fee Rates

FDA is republishing fee rates for the over-the-counter (OTC) monograph drug user fee program. A Federal Register notice says the rates were authorized under the 3/2020 Coronavirus Aid, Relief, and Economic Security Act to support the modernization of the OTC monograph program.

After the fees were initially published in a 12/29/20 Federal Register notice, FDA determined that they should not be applied to companies that first entered the OTC market on or after 1/27/20 solely to produce hand sanitizer during the Covid-19 public health emergency. FDA says the initial notice has been withdrawn and the rates are now being republished.

CDER acting director Patrizia Cavazzoni says FDA is aware that because some hand sanitizer companies will not be paying facility fees, other firms will see an increase in the FY 2021 fees they will pay compared to those in the withdrawn fee notice. “However,” she says, “by supporting OTC monograph reform efforts, these fees will aid in improving the efficiency, timeliness, and predictability of the review process for OTC monograph drugs.”

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