Drugs

Concerns on Drug Quality Metrics Proposal Aired

The International Society for Pharmaceutical Engineering (ISPE) says it recognizes and thanks FDA for applying the lessons learned from the pilot Quality Metrics Site Visit Program and the Quality Metrics Feedback Program in developing an agency quality metrics reporting program proposal. In a comment letter, ISPE raises issues relating to (1) balance of quality metrics and quality management maturity;(2) proposed practice areas and metrics; (3) frequency of reporting; and (4) additional considerations.

The Parenteral Drug Association says it “believes that the use of metrics as a tool in understanding performance is an important part of improving processes, systems, and culture.” The association says FDA should ensure that the metrics program does not become a strict compliance requirement “as that would likely lead to unintended consequences and behaviors that are counterproductive to developing a good quality culture and continuous improvement mindset.” The letter provides several questions about the proposal for which it says industry would appreciate additional detail.

In its comment, Pfizer says that in principle it agrees with the proposed direction for the quality metrics program described by FDA and the flexibility on what metrics are reported and the allowance for establishments to be able to define how to calculate metrics.

GlaxoSmithKline submitted its answers to questions about the proposal posed by FDA in its request for comment.

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