FDA Policy/General

Allure Imports Selling Unapproved, Misbranded Covid-19 Drugs: FDA

FDA and the Federal Trade Commission say their review of Web sites and social media sites maintained by Allure Imports, Sault Sainte Marie, MI, established that the company markets products that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in humans or animals. A 4/7 Warning Letter says the products are unapproved new human or animal drugs that also are misbranded.

The letter lists examples of claims made by the company establishing the products’ intended use and misleadingly representing them to be safe and/or effective for treating or preventing Covid-19.

Allure was advised to review its Web sites, product labels, and other labeling and promotional materials to ensure that the company is not misleadingly representing its products as safe and effective for a Covid-19-related use for which they have not been approved by FDA and that the company does not make claims that misbrand the products. It was told to respond with a list of specific steps taken to address the violations with an explanation of each step and copies of related documentation.

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

Read more

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