Drugs

FDA, European Regulators Back GCP Inspection Collaboration

A new research article by FDA and European regulators finds their good clinical practice (GCP) inspection processes to be equivalent, which supports an ongoing inspection collaboration and inspection document sharing pact. Writing in the 8/16 online Therapeutic Innovation & Regulatory Science journal, the regulators said they analyzed 55 shared applications — 28 of which included common sites inspected by both agencies. There were 15 joint inspections conducted for seven of these applications and the remaining applications had common sites inspected by both agencies at separate times.

“The median time from submission of an application to generation of final inspection reports was 232 days for FDA and 204 days for the EMA [European Medicines Agency], with no significant differences noted among applications with and without common sites,” they write. “The inspection processes and timelines between the two agencies were similar, providing support for continued FDA-EMA GCP collaboration.

The FDA/EMA GCP collaboration includes bimonthly meetings to discuss the status and/or findings from inspections for shared applications, exchanging inspection documents, and identifying sites for potential joint or observational inspections.

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