Drugs

Firm Selling Misbranded, Unapproved New Drugs: FDA

FDA says its review of a Web site maintained by Molecular BioLife, Sheldon, IA, determined that the firm takes orders for Shark 2 Collagen and Balanced Kollagen. A just-released 4/15 Warning Letter says the claims on the firm’s Web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Introducing or delivering the products for introduction into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act, the letter says.

FDA lists many of the Web site’s claims that establish the products as drugs and notes that they are not generally recognized as safe and effective for their intended use and thus are legally considered new drugs. They also are misbranded because they fail to bear adequate directions for their intended uses.

Molecular BioLife was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with copies of related documentation, and a timetable for completing the corrections.

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