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.

Hangzhou Guoguang Touring Commodity Co. Zhejiang, China (12/14): FDA inspected the firm 4/2018 and cited it for significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. Additionally, the firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. FDA recommended that the firm retain a consultant to help it achieve GMP compliance.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm628942.htm

University of Miami Reproductive and Fertility Center Miami, FL (12/3/2018) FDA inspected the center 7/2018 and cited it for significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. For example, the center failed to determine as ineligible several donors who were identified as having a risk factor that would exclude them. Additionally, the center failed to prominently label a cell/tissue product with a “biohazard legend” if results of any screening or testing performed indicate risk factors for, or clinical evidence of, communicable disease agents or diseases.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm629069.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