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.

Diasol, Inc. San Fernando, CA (9/25): FDA inspected the firm in June and cited GMP deviations with liquid and powder dialysate concentrate products and liquid and powder sodium bicarbonate products for use in hemodialysis systems. For example, the firm failed to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. The firm also failed to establish and maintain a design history file for each type of device. Additionally, FDA says the firm failed to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580196.htm

Kelyniam Global Canton, CT (10/5): FDA inspected the firm in May and cited GMP deficiencies with patient-specific cranial implants and maxillofacial implants. For example, the firm failed to establish and maintain design change procedures. It also failed to evaluate complaints to determine whether the complaint represents an event which is required to be reported to FDA. And it failed to demonstrate that the device was manufactured in accordance with the device master record.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580281.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