Drugs

‘Mixed Reality Device’ CGMP Inspection Success

Researchers say a pilot program using a mixed reality device with a collaborative text messaging system allowed multiple national regulatory authorities, including FDA, to perform a regulatory inspection of a good manufacturing practice (GMP) facility simultaneously, while still following their respective internal procedures. Writing in Therapeutic Innovation & Regulatory Science, the researchers say remote inspections can reduce the number of on-site inspections any company may have to host, by effectively allowing multiple regulatory agencies to inspect simultaneously.

“The use of a mixed reality device and Microsoft Teams platform to perform a GMP inspection including multiple national regulatory authorities is feasible,” the article concludes. “Further testing of improved versions of the technology will provide a more seamless experience for inspectors on-site and participating virtually.”

In the pilot mock inspection at a U.S. drug manufacturing facility conducted by two former FDA investigators, with participation by representatives from several other regulatory authorities, the representatives were able to interact directly with the on-site inspectors, one of whom was wearing a virtual reality headset. The representatives were able to ask specific inspection questions, evaluate the facility, and review requested documents, the report says.

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