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.

Family Pharmacy, Statesville, NC (11/6): FDA inspected the firm 2/3-2/12 and cited multiple drug compounding and GMP violations. For example, it failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions. It also failed to adequately design the facility with adequate separation or defined areas or such other control systems necessary to prevent contamination or mix-ups. To view the Warning Letter, click here.

Quten Research Institute, Pine Brook, NJ (11/5): FDA recently reviewed the firm’s Web site and determined that it takes orders for Qunol Ultra CoQ10 and Qunol Extra Strength Turmeric. The claims on the Web site make the products unapproved new drugs. For example, one claim said: “Researchers theorize that some people that suffer from high blood pressure also exhibit CoQ10 deficiency. Multiple studies have reported that CoQ10 had a blood pressure lowering (hypotensive) effect and that this might be caused in part by correcting this deficiency.” The letter told the company to take prompt action to correct the cited violations. 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