Drugs

State of Pharmaceutical Quality Report Out

CDER has issued its latest “Report on the State of Pharmaceutical Quality,” a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality pharmaceutical products. The report says CDER’s Office of Pharmaceutical Quality monitors the quality of CDER-regulated drugs legally marketed in the U.S. It defines a quality drug as one that is “consistently safe and effective, free of contamination and defects.”

The yearly objective assessment of drug quality uses indicators based on available FDA drug product-specific and manufacturing site-specific data. FDA says the information is specific to drugs marketed in the U.S. and to registered human drug manufacturers engaged in U.S. interstate commerce (not including medical gas and drug compounding and outsourcing facilities). It says it includes data from foreign agency site inspections recognized under the mutual recognition agreement.

The report says OPQ “uses the State of Pharmaceutical Quality to, among other things, inform regulatory decision-making and surveillance activities. OPQ also provides this information to internal FDA business partners to inform their operations. We are now providing this information publicly so our external stakeholders can better understand the quality of the U.S. drug supply, we can better engage the pharmaceutical manufacturing industry in a commitment to quality, and we can better inform patients and consumers.”

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