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.

CTX Lifesciences, Gujarat, India (7/12): FDA inspected the firm in February and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, CTX failed to ensure that water used in the redacted manufacturing steps of a non-sterile API intended for a sterile drug product is monitored and controlled for total microbial counts, objectionable organisms, and endotoxins. It also failed to adequately investigate out-of-specification results and implement appropriate corrective actions. To view the letter, click here.

Ningbo Pulisi Daily Chemical Products, Yuyao City, China (8/13). FDA inspected the firm in February and cited it for significant GMP violations for finished pharmaceuticals. For example, Ningbo failed to perform, for each batch of drug product, appropriate laboratory determinations of satisfactory conformance to final specifications for the drug products. It also failed to follow an adequate written testing program designed to assess the stability characteristics of drug products. And the company failed to establish written procedures for production and process controls. 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