Drugs

Consumer Antiseptic Rub Final Rule Q&A

FDA has published a guidance, Consumer Antiseptic Final Rule Questions and Answers, to help small businesses understand and comply with the antiseptic rub final rule that applies to active ingredients used in over-the-counter (OTC) consumer antiseptic rub products, sometimes referred to as rubs, leave-on products, or hand sanitizers. The document says the final rule also applies to active ingredients used in OTC consumer antiseptic wipes.

The guidance says the final rule established that 28 active ingredients used in OTC consumer antiseptic rub products are not eligible for evaluation under the agency’s ongoing rulemaking to evaluate the safety of OTC drug products. Rather, drug products containing these active ingredients will require approval under a NDA or ANDA before they can be marketed, it says.

The final rule established that three active ingredients used in the products — benzalkonium chloride, ethyl alcohol, and isopropyl alcohol — are eligible for evaluation under OTC drug review.

The final rule was published 4/12/19 with an effective date of 4/13/20. On 3/27/20, President Trump signed the Coronavirus Aid, Relief, and Economic Security (CARES) Act that included an OTC monograph reform process. FDA says the law replaces the rulemaking process with an administrative order process to add, remove, or change an OTC monograph.

FDA says it is implementing the changes outlined in the CARES Act and that the legislation does not affect the agency’s findings in the consumer antiseptic rub final rule.

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