Drugs

Debarment Order Against Louis Daniel Smith

Federal Register Notice: FDA has issued a debarment order against Louis Daniel Smith from providing services in any capacity to a person that has an approved or pending drug product application. The order us based on Smith having been convicted of felonies under federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product. Smith was a managing member of PGL International, which marketed and sold various health-related products, including Miracle Mineral Solution (MMS), a mixture of sodium chlorite and water which cannot be sold for human consumption. Smith obtained chemicals needed to manufacture the misbranded drug MMS without revealing to regulators and suppliers the true purpose of the chemicals; used those chemicals to manufacture the misbranded drug MMS in a facility that was not disclosed to regulators; offered the misbranded drug MMS for sale on Web sites he had established; and sold that drug in interstate commerce. To view the notice, click here.

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