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.

Health Pharma USA Rahway, NJ (12/18): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, the company’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with GMPs, and meet established specifications for identity, strength, quality, and purity. Additionally, Health Pharma failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced. To view the letter, click here.

Huaian Zongheng Bio-Tech Jiangsu Sheng, China (1/9): FDA inspected the firm in July and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to have appropriate laboratory determinations of satisfactory conformance to final specifications for its drug products. It also failed to conduct at least one test to verify the identity of each component of a drug product. Additionally, it failed to establish and follow an adequate written testing program designed to assess the stability characteristics of its drug products. To view the letter, click here.

James W. Findling Milwaukee, WI (12/31): The letter cites objectionable conditions observed during a July Bioresearch Monitoring Program inspection conducted at the investigator’s clinical site. For example, the agency said the investigator failed to ensure that the investigation was conducted according to the investigational plan. FDA also said that failure to perform protocol-required procedures, particularly those related to discontinuation from randomization due to elevated laboratory values, raises significant concerns about the adequacy of the protection of study subjects enrolled at the study site. 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