Shannon Brown
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
FDA Email Alert: Next Day’s Manufacturing Volume Reporting Due Date Still Voluntary
Objections to 15 February reporting date established in draft guidance spurred rare last-minute notice assuring industry that it was a non-binding recommendation, not a requirement. Action reflects confusion that can arise in interpreting policy guidance.
Pharma Supply Chain Disruptions Increased Another 74% in 2021, Resilinc Says
The COVID-19 pandemic has both caused problems such as reduced preventive maintenance and exacerbated other issues, such as slowing recovery from extreme weather events, according to Resilinc CEO.
GAO Advises US FDA On Inspection Pilot Plans; Notes Increased Oversight Of OAI Downgrades
As omicron COVID-19 variant recedes, GAO shares thoughts on FDA’s plans for unannounced foreign inspections and translation services pilots. The report also details agency efforts to fill vacant foreign inspection positions.
Robotic Aseptic Filling Could Help Production, But Faces Regulatory Inconsistency
Use of robotic aseptic manufacturing techniques is increasing, but regulatory agencies are giving conflicting feedback, according to an industry executive. The dilemma points to the need for more development of and consistency in regulation for advanced manufacturing.
GAO Examines How US Learned To Use Defense Production Act More Effectively Against COVID-19
Report says agencies took steps to use DPA more effectively, but HHS still working on a strategy for DPA use that will strengthen domestic supply chains and manufacturing.
Industry Balks At Deadline For New Manufacturing Volume Reporting Requirements
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.