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.

Dynavision International West Chester, OH (9/5): FDA inspected the firm in April and determined that its Dynavision D2 product is misbranded because there have been major changes or modifications to the intended use without a new 510(k) being submitted. Specifically, FDA said the previous model, Dynavision 2000, was cleared under K911938 with the indication for use stated as “measurement of reaction time.” However, its current promotion of the device provides evidence that the device is intended for a number of indications not cleared under this 510(k). “Any therapeutic or rehabilitation claims and/or any diagnostic claims beyond the measurement of reaction time constitute a new intended use and require submission of a 510(k) prior to marketing of the device for such claims,” the letter said.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574774.htm

HomeoCare Laboratories Yonkers, NY (9/7): FDA inspected the firm in January and documented significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written procedures for production and process controls. The firm also failed to establish and follow adequate written procedures designed to assure batch uniformity and integrity of drug products that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575120.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