FDA To Create Quality Metrics To Help Fine-Tune Risk-Based Enforcement
This article was originally published in The Tan Sheet
FDA will work with stakeholders to identify quality indicators that drug firms would track and report to help the agency improve surveillance and fine-tune risk-based criteria for inspections and enforcement, FDA’s Sklamberg said. CDER’s Office of Compliance also is focused on improving supply chain oversight and clarifying contract manufacturer responsibilities.
You may also be interested in...
Batch failure and other measures manufacturers commonly track could be aggregated into an industry-wide index FDA would use to help make inspection decisions. CDER compliance chief Howard Sklamberg says FDA wants more predictive measures to find quality issues, rather than lagging metrics such as recalls or adverse events.
J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.
GlaxoSmithKline restructures its management to ensure adequate focus on its three core areas, pharmaceutical, vaccine and consumer. Consumer product sales fell 3% to $1.72 billion in the third quarter due to continuing supply interruptions and generally weaker markets.