Drugs

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.

Dae Young Foods Co. Seoul, Korea (11/20): FDA inspected the firm in March and documented significant GMP violations for finished pharmaceuticals. For example, the firm failed to visually examine each container of components for appropriate labeling as to its contents. The firm also failed to conduct at least one test to verify the identity of each component. Additionally, FDA reviewed the product labeling for its Smoker’s Appetite Relief and determined that it is misbranded.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm586501.htm

JMA Partners, Inc., dba Guardian Pharmacy Services Dallas, TX (11/3): FDA inspected the firm in 2016 and noted serious deficiencies in its practices for producing sterile drug products. FDA noted that it received numerous adverse event reports from April to June, and it conducted follow-up discussions concerning at least 43 patients who experienced vision impairment and loss after being administered intravitreal injections of a drug containing triamcinolone and moxifloxacin compounded by the firm. The agency said it continues to investigate the adverse events. During the inspection, FDA found that the firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products it produced. It was also determined that the firm compounded drug products using grape seed oil, which are not eligible for exemptions provided by FDA regulations.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm586119.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