Drugs

Warning Sent to Maison Terre After Infant Death

FDA 4/1 issued a Warning Letter to Maison Terre after conducting testing on its drug product labeled as “Goldenseal Root Powder Organic” and determining the repackaged product was prepared, packed, or held under insanitary conditions. The letter said the agency was aware of a report of one infant death associated with the drug product’s use on the umbilical cord stump.The agency also said the product was considered an unapproved new drug.

FDA said that its testing found the product to be contaminated and contained more than 260,000 cfu/g of total aerobic microbial growth and more than 5,000 cfu/g of total yeast and mold growth. “Moreover, FDA laboratory testing also found that your ‘Goldenseal Root Powder Organic’ drug product contained the presence of several objectionable microorganisms, including but not limited to: Enterobacter cloacae, Klebsiella pneumoniae, and Cronobacter sakazakii. These are significant opportunistic pathogens that can cause serious infections and diseases.”

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