FDA Policy/General

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Evolved Ayurvedic Discoveries, Encinitas, CA (2/11): FDA reviewed the company’s Web site, Facebook and Instagram pages and determined that the company takes orders for several BioCBD+ products that claim to contain cannabidiol and are considered unapproved new drugs. The company’s BioCBD+ Peace Vape product was also singled out because the ingredients and potential impurities in oral inhalation products may trigger laryngospasm and bronchospasm and may be toxic to tissues in the upper or lower airways. To view the letter, click here.

AcelRx Pharmaceuticals, Redwood City, CA (2/11): An FDA review of the company’s promotional materials for AcelRx’ Dsuvia (sufentanil) sublingual tablets make false or misleading claims and representations about the drug’s risks and efficacy. For example, the agency cited the banner ad for omitting information from the labeling on the maximum daily dosage and thus creates a misleading impression about the safe use of the drug. The banner also fails to convey material information about the drug’s limitations of use, thus creating a misleading impression. The letter also analyzes issues with other claims and statements in the promotional materials. To view the letter, 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

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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