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.

ForYou, Inc., Loris, SC (10/20): FDA inspected the firm 2/19-2/21 and found significant GMP violations for dietary supplements, among other citations. The agency says that several of the firm’s products are considered to be unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. Significant violations cited include failing to establish and follow written procedures for the responsibilities of the quality control operations, failing to establish and follow written procedures for holding and distributing operations, and failing to establish and follow written procedures to fulfill the requirements that apply to the review and investigation of product complaints. To view the letter, click here.

Industry Lab Diagnostic Partners, Nashville, TN (11/20): FDA recently reviewed the company’s Web site and determined that the firm is offering a Covid-19 at-home sample collection kit that is considered a medical device, which is being marketed without approval, clearance, or authorization from the agency. FDA also says the kit is adulterated and misbranded. The company was told to take immediate action to prevent future violations and to respond with a description of the specific steps it has taken to prevent future violations and copies of related documentation. 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