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.

Guangzhou Tinci Materials Technology, Guangzhou, China (1/23): FDA inspected the company 7/29 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, and adequate size for its intended use and for its cleaning and maintenance. It also failed to conduct, for each batch of drug product, appropriate laboratory testing required to be free of objectionable microorganisms. To view the letter, click here.

James R. Corbett, Ann Arbor, MI (2/27): FDA inspected the clinical investigator’s site 6/2019 and cited objectionable conditions with the clinical investigation of an undisclosed drug product. For example, FDA says Corbett failed to maintain an effective IND with respect to the investigations. He also failed to promptly report all changes in research activity to the Institutional Review Board. And, he failed to ensure that the investigation was conducted according to the investigational plan. 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