Drugs

Changes Recommended in Draft Quality Metrics Guidance

Perrigo says the flexibility provided by FDA in a revised quality metrics draft guidance to allow reporting by site or by product “has the potential to create added confusion for key partners across the supply chain due to the potential for some partners to prefer site reporting and others to prefer consolidated product reporting.” The comment letter says Perrigo recommends that metric data be collected and reported by site to reduce the complexity burden and assure transparency. The company also asks for more flexibility in metrics so that companies and sites may use specific definitions that fit their processes and may be more consistent with currently collected data and metrics.

In its letter, Gilead asks for further clarity on FDA’s approach to enforcement after the voluntary phase of metrics collection. It also says that for products manufactured at multiple sites, preference should be given to the product reporting rather than the site reporting option.

Celgene praises the draft for contributing to the foundation of a global quality mindset across the industry. It says it encourages the agency to first understand what utility it is seeking with the metric data for the short and long-term, how it plans to validate the data, and how it will share such plans with the public.

Specific line-by-line comments on the draft were submitted by Baxter, Allergan, and Sanofi.

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