Drugs

Mutual Reliance Initiative Expands Drug Inspections

FDA associate commissioner for global regulatory policy Dana Corrigan says a Mutual Reliance Initiative (MRI) with the European Union (EU) allows FDA and EU inspectors to work together, relying on each other’s inspections, avoiding duplication, and conducting more inspections. Writing in an FDA Voice blog post, Corrigan says the MRI was launched 5/2014.

As part of the implementation, she writes, the two regulatory bodies assembled dedicated teams to assess the risks and benefits of entering into a mutual recognition agreement. As part of the process, FDA has been invited to observe 13 joint audits in which two EU nations audit the regulatory authority of a third member country.

“This unprecedented access allows FDA observers to gather firsthand knowledge of the laws that govern EU GMP drug inspections and how inspectorates (regulatory authorities) manage the drug inventory within their respective borders,” Corrigan says. “Also, interacting with auditors across the EU provides a unique opportunity to understand the regulatory framework in the EU.”

The post notes that the UK’s coming departure from the EU has had no impact on FDA relationships. It is anticipated that once the “Brexit” is completed, FDA and the UK will examine existing commitments and, if necessary, renegotiate any agreements, it says.

Corrigan says FDA hopes to sign an agreement with the EU soon and is working to complete assessments of the capability of the drug manufacturing inspectorates of two to four countries in the EU. “These first steps with the EU will lead toward our goal of an expanded inspectorate, containing investigators and inspectors from FDA and from across the EU,” she concludes. “These collaborations will enhance our ability to evaluate risk, produce better data, and minimize public health risk globally.”

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