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.

Jiangsu NHWA Pharmaceutical Co., Jiangsu, China (9/10): FDA inspected the firm in April and cited significant GMP deviations for active pharmaceutical ingredients (APIs). For example, the company failed to ensure that all sampling plans and test procedures are scientifically sound and appropriate to ensure that APIs conform to established standards of quality and purity. Jiangsu NHWA also failed to adequately investigate and document out-of-specification results according to procedures and implement appropriate corrective actions. To view the letter, click here.

Sofie Co., Dulles, VA (10/10): FDA inspected the firm in April and cited GMP violations for positron emission tomography drugs. For example, Sofie’s facilities were found inadequate to prevent contamination of equipment or products by environmental conditions. FDA said environmental monitoring trend data frequently identified fungal contamination on operator glove, air, and surface samples. It noted that similar GMP violations were documented at another facility in your company's network, N-Molecular Inc. dba Sofie, which received a Warning Letter 9/24/2018. 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