Drugs

Clarke Pharmaceuticals Marketing Unapproved Drugs Online: FDA

An FDA review of a Web site and YouTube channel maintained by Clarke Pharmaceuticals, Webster, TX, found the firm is marketing several unapproved drugs, according to a 2/2 Warning Letter. The letter quotes claims from the firm’s Web site that establish the products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

The letter says the firm’s products are not generally recognized as safe and effective for their intended uses and thus are considered to be new drugs that FDA has not approved. They also are misbranded because they don’t contain adequate directions for use.

Clarke was told to take prompt action to address the violations and establish and implement procedures that will prevent the recurrence of these and any other violations. It was told to respond with a list of specific actions taken to address the violations, documentation of each action, and a schedule for completing the actions.

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