Drugs

Immune & Genetics Protocols Marketing Unapproved Drug: FDA

FDA says Immune & Genetics Protocols, Ocala, FL, is marketing Immune Bio Green Cell, which is considered to be a drug because it is intended for use in curing, mitigating, treating, or preventing disease. A just-released 3/30 Warning Letter lists some Web site claims the company makes for its product and a list of diseases and conditions that it claims may benefit from Bio Green Cell.

FDA says the firm Web site also contains testimonials recommending or describing the use of Bio Green Cell for the cure, mitigation, treatment, or prevention of disease.

Bio Green Cell is not generally recognized as safe and effective for its indicated uses, the agency says, and thus is an unapproved new drug. The product also is misbranded because it does not contain adequate directions for use.

The letter also notes that the firm’s Web site says Bio Green Cell is approved for sale by the U.S. Department of Agriculture and is manufactured and produced in a laboratory approved by FDA. It says the USDA does not approve drugs or dietary supplements and FDA says it has no registration record for the company’s facility.

Immune & Genetics Protocols was told to respond with a list of specific steps it has taken to address the violations, with documentation for each action and a timetable for completing the work.

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