Drugs

CGMP Violations at Jiangsu NHWA

A 4/1-4/5 FDA inspection at Jiangsu NHWA Pharmaceutical Co., Jiangsu Sheng, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs). A just-released 9/10 Warning Letter says specific deviations were:

failing to ensure that all sampling plans and test procedures are scientifically sound and appropriate to ensure that the company’s APIs conform to established standards of quality and purity; and
failing to adequately investigate and document out-of-specification results according to a procedure and implement appropriate corrective actions.

The letter says the firm’s products are also adulterated for failing to conform to compendial standards for strength, quality, or purity. It acknowledges the company’s commitment to cease distribution of drugs manufactured at the site to the U.S. market until it has completed its corrective and preventive action plan and confirmed its effectiveness.

Jiangsu was told to respond with a list of steps taken since the inspection to correct the deviations and prevent their recurrence, with an implementation schedule.

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