Drugs

Stakeholders Support Records Guidance

AdvaMed says the current 2003 FDA guidance on using electronic records and signatures in medical product clinical investigations is outdated and uses enforcement discretion. In its comment on a new draft guidance, the trade association says it supports the risk-based approach to validation and audit trails outlined in the draft guidance that will help encourage and support use of modern technologies in medical device clinical trials. It also says it strongly supports the guidance approach to mobile technologies that will facilitate their use in clinical trials by establishing reasonable approaches. The association suggests a number of ways in which it believes the draft could be improved.

Novartis says that overall, the draft is “pragmatic, forward-looking, and a welcome companion “ to three other documents. It also recommends several changes for FDA to consider.

QuintilesIMS notes that a parallel guidance was issued for systems used in good manufacturing practice operations and asks the agency to consider identifying common expectations across all good practice areas and note particular or unique expectations for good clinical practice use as a section of the cross good practice guidance.

A Johnson & Johnson comment letter “welcomes and commends FDA for a thoughtful guidance to aid in adoption of newer technologies, e.g., mobile apps, wearable technologies, and sensors into clinical investigation.” The company says it generally supports the comments submitted by AdvaMed.

Specific line-by-line comments were submitted by GlaxoSmithKline and AstraZeneca.

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