Drugs

‘Significant Opportunities’ for FDA Cloud Adoption: Report

An Eagle Hill consultants’ report says FDA has significant opportunities to benefit from further adoption of computer cloud technology if the agency can overcome obstacles identified in the report. The report was produced as part of an agency commitment in PDUFA 7 to “leverage cloud technology to progress regulatory digital transformation” by assessing “challenges or barriers in adoption of cloud-based technologies in applicant-regulator interactions.”

The report says it provides a qualitative assessment of FDA’s progress to date in implementing cloud technology within CDER and CBER, key challenges to future cloud adoption, and opportunities for improvement.

“FDA has taken significant steps to migrate many of its core business functions to the cloud,” the consultants write. “It has established access to multiple cloud environments including the Amazon Web Services GovCloud and the Microsoft Azure clouds and has made significant progress in addressing the challenge of meeting stringent data security expectations while migrating to cloud-based solutions.”

The consultants also found that FDA faces technical, financial, process, and policy challenges that affect its interactions with industry stakeholders and its ability to benefit from cloud solutions. Examples of these challenges, they say, include maintaining high-performance cloud solutions while meeting federal IT compliance and cybersecurity requirements, streamlining complex hybrid multi-cloud enterprise architecture, re-training existing or hiring new FDA staff to meet knowledge and skill requirements for cloud solutions, and interpreting aged policy language in the context of modern cloud technology.

“Leveraging earlier successes while making strategic investments through careful planning will put FDA on a more optimal journey to the cloud,” the authors conclude.

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