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The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices without authorization, including devices for eyelid cleaning and an infection control system. Additionally, the agency sent an untitled letter to a company regarding misleading promotional communications for a prescription migraine drug.

BALTIMORE – Experts who spoke at the RAPS Quality Conference on Wednesday said that a successful quality culture must come from the top and be continuously reevaluated. They added that employees need to feel empowered to ask questions and trust that their company is transparent with them.

BALTIMORE – Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for failing to meet their quality management requirements, according to a top agency official. She emphasized that companies need to treat risk management as an ever-evolving responsibility.

BALTIMORE – Kerri DiPietro, chief quality officer at Integra LifeSciences, said that drug and device makers need to be methodical and purposeful when considering elevating their companies' quality cultures. She noted that it involves getting buy-in from key leadership, measuring the progress, and implementing a plan that may take years to accomplish.

The US Food and Drug Administration (FDA) recently sent warning letters to two facilities in the United States and Mexico for failing to comply with current good manufacturing practices (cGMPs) related to contamination issues and data integrity problems. The agency also warned a company in Brazil for failing to respond to a request for written records and to a laboratory in the US for nonclinical study violations.

The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative efficacy studies.

The Pharmaceutical Research and Manufacturers of America (PhRMA) has stated that the ICH M4Q(R2) involves a significant restructuring of the quality section of the Common Technical Document (CTD), bringing major changes for both the industry and regulators. As such, ICH and regulatory authorities should promote global synchronization of the guideline’s implementation to reduce the need for maintaining dual dossier structures.