Drugs

CDER Sets Up New Drug Compounding Compliance Team

CDER’s Office of Compliance has set up a new compounding team with responsibility for the overall management of the agency’s drug compounding compliance program. According to an email from CDER director Janet Woodcock, Division of Compounded Drugs director Gail Bormel will lead the team and report directly to Office of Compliance director Donald Ashley.

The team is part of the agency’s implementation of the Drug Quality and Security Act (DQSA) which mandated improved compounding oversight. Woodcock said that “other CDER offices will continue to handle important aspects of the program. For example, the Office of New Drugs (OND) will continue to review bulk substances, the Office of Pharmaceutical Quality (OPQ) will continue to develop current good manufacturing practices policies for outsourcing facilities, and the Office of Regulatory Policy (ORP) will collaborate on guidances and regulations.”

Under the DQSA, Woodcock said, FDA has “substantially increased oversight of the compounding industry. For example, last year, we inspected 128 compounders, issued 24 Warning Letters, oversaw 54 recalls, issued four Compounding Risk Alerts, and enjoined two compounders. We also continued significant policy development efforts, including the issuance of 13 guidance documents in 2018. This year, Congress also established a dedicated funding stream to support continued compounding oversight activities by the agency. This will allow for the development of an even more robust compounding program in the years ahead.”

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