Drugs

Stakeholder Ideas on FDA Electronic System Draft

AdvaMed says it “strongly supports FDA’s efforts to provide recommendations regarding requirements in clinical investigations for when electronic systems, electronic records, and electronic signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.” The association’s comments responded to an FDA draft Q&A guidance. Noting that the agency recommends conducting a risk-based assessment, such as for a decision to review an audit trail, AdvaMed says it would help if FDA gave examples of how a sufficient risk-based assessment can be conducted for different types of systems. The letter says it would also help to understand when FDA generally thinks that only performing user acceptance testing is adequate versus more robust types of validation.

AstraZeneca says it agrees that the guidance is necessary to supersede one earlier guidance and revise another. It provides a chart with specific line-by-line comments. Also giving a chart with specific comments was Bayer.

The International Society for Pharmaceutical Engineering suggests more clearly defining some terms in the draft and adding a comment relating to the information being maintained electronically. It also proposes specific line-by-line changes.

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