Drugs

FDA/EMA Pilot Program Aims to Harmonize Inspections

An ongoing FDA/European Medicines Agency (EMA) pilot program on good clinical practice (GCP) inspections has shown promising results that could lead to greater harmonization and eventual mutual recognition of inspection reports, according to officials from the regulatory agencies. Speaking at a Drug Information Association session in Chicago 6/20, CDER Office of Scientific Integrity medical officer Jenn W. Sellers noted that a review of common inspections involving studies cited in FDA and EMA marketing applications since 2009 found that inspectors from both agencies had similar deficiency rates (90%) when examining clinical investigator protocol violations and reporting issues. There was also “high concordance (90%)” between FDA and EMA sponsor/contract research organization inspection findings involving trial management issues. She said there was even a “good concordance rate (75%)” involving inspection issues related to trial documentation (source documents, protocol, training records, etc.).

In breaking down common findings by FDA investigators during GCP inspections, Sellers said the most frequent finding (27% of inspections) involved protocol violations, such as eligibility or efficacy/safety protocol violations or reporting issues. The next most common finding was trial documentation (21% of inspections), which includes source documents, essential documents, and enrollment/training records. Additionally, study drug citations (drug supply or accountability) and informed consent violations were seen in 15% of the inspections, respectively.

Sellers said the next step in the pilot will finalize the comparison of GCP findings between the two agencies. “Based on the results of this project, recommendations will be made on how to strengthen regulatory convergence and harmonization,” she said.

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