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.

CooperSurgical, Trumbull, CT (2/12): CDER’s Office of Prescription Drug Promotion (OPDP) cited the firm’s direct-to-consumer video for Paragard (intrauterine copper contraceptive) as false and misleading due to presenting product efficacy claims and failing to communicate any risk information associated with its use. OPDP says that referring viewers to a Web site for further information does not mitigate the complete omission of risk information from the video. It also says the company failed to submit a copy of the video at the time of initial dissemination with a copy of the FDA-2253 as required by regulations. To view the letter, click here.

Dr. Paul's Lab, Mazomanie, WI (2/16): FDA has reviewed the firm’s Web site (http://drpaulslab.net) that directs consumers to various dealers to purchase its product, which the agency determined is an unapproved drug because it is intended to mitigate, prevent, treat, diagnose, or cure Covid-19. For example, FDA objected to the following claim: “Covid-Aid Tincture . . . Directions: If illness [is] suspected, take 1 cc (1 dropperful) under tongue 4–6 times daily until symptoms subside.” 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