Shannon covers pharmaceutical quality, manufacturing, and regulatory topics for Informa. She is also interested in environmental issues and covers sustainability initiatives in manufacturing. She started her career as a writer and editor at the US National Cancer Institute. After several years of freelancing for healthcare and environmental outlets, she received an MA in Science Writing from Johns Hopkins University and started at Informa.
Hailing from Oahu, Hawaii, she enjoys travel and is also an avid reader and practitioner of yoga. She speaks Spanish and elementary German.
Latest From Shannon Brown
Comments cite requests for delayed or phased implementation, question how data will be used, and ask whether current reporting avenues could be used to gather similar information, among other concerns.
As the response to another wave of COVID-19 infections continues, fill rates of critical medicines such as methylprednisolone are dropping. But experts say the answer is not to concentrate manufacturing in US facilities, which could lead to further risks if US supply is disrupted.
Guidance aligns with USP Chapters <790> and <1790>; encourages risk-based approach to identifying and correcting particulate contamination of sterile injectables to build on recent successes in reducing particulate-driven recalls.
In Cleveland and Moscow, researchers found freshly-manufactured T-cells showed faster reduction of tumor burden than cryopreserved cells, but uncertainty remains about what the clearance process for the technology will be at the US FDA.
ICH Q9 draft published for public consultation; changes focus on addressing subjectivity in quality risk management and managing risk for supply chains, among other topics.
After lapsing due to COVID-19, an unannounced foreign inspection pilot program is on track to resume in 2022, “despite challenges and constraints of travel.”