FDA Policy/General

Company Selling Illegal New Drugs for Humans and Animals: FDA

FDA says its review of a Web site and Amazon storefront maintained by Fresh Nutrition, Inc., Yorba Linda, CA, determined that the company is taking orders for several products that are legally considered to be drugs for use in diagnosing, curing, mitigating, treating, or preventing disease in humans and animals. A 5/27 Warning Letter lists many of the claims the company makes for its products that indicate they are drugs.

The letter says the products for humans are not generally recognized as safe and effective for their intended uses and thus are considered new drugs that cannot be legally introduced into interstate commerce without prior FDA approval. The products also are misbranded because they do not contain adequate directions for use.

The letter provides the same explanation for the unapproved new animal drug the company sells.

Fresh Nutrition was told to respond with a list of specific steps it has taken to address any 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