Drugs

FDA Warns Dollar Tree on Unsafe OTC Drugs

FDA has issued a Warning Letter to Dollar Tree discount stores for receiving over-the-counter drug products produced by foreign manufacturers that were found to have “serious violations of federal law.” The letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce the company’s Assured Brand OTC drugs as well as other drug products sold at Dollar Tree and Family Dollar stores.

An agency notice says the Warning Letter “details Dollar Tree’s receipt of adulterated drugs from manufacturers that received FDA Warning Letters in 2018. The Warning Letter also details Dollar Tree’s use of contract manufacturers that also received Warning Letters for similar issues between 2016 and 2019.” The agency says it notified Dollar Tree of Warning Letters sent to the manufacturers at the time the letters were sent.

The letter to Dollar Tree details corrective actions sought by FDA, including implementation of a system to ensure that it does not import adulterated 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