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.

A-S Medication Solutions Libertyville, IL (6/5): FDA recently reviewed the firm’s listing files and has identified many instances where the listing information failed to comply with the applicable requirements. Listing errors identified in 2016 listing files and brought to the company’s attention have still not been corrected.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm562143.htm

Belmora Arlington, VA (6/8): FDA recently reviewed the company’s Web site that markets Elavil OTC Sleep Aid and the claims on the site make the product an unapproved drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. For example, the agency objected to the following claim: “Just promoting drowsiness is solving only half of the insomnia problem… The other half of the insomnia problem is Stage 3 Sleep and REM Sleep, the deeper sleep your body needs to experience for you to wake up feeling refreshed…Elavil OTC Sleep is a complete solution to insomnia because it was formulated to work on all four stages of sleep.”
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm562532.htm

The See Clear Company Norcross, GA (2/14): FDA inspected the firm 10/2016 and cited GMP deficiencies associated with its soft contact lenses for daily wear under the brand names Circle Collection, Diamond, Fierce, Fright, Ambition, See Clear, See Clear Color and Lunatic. For example, the firm failed to establish and maintain procedures for implementing corrective and preventive action. It also failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm562605.htm

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