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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

US FDA ‘Quietly Working Hard’ To Develop Advanced Manufacturing Framework

Soon-to-be-released white papers will FRAME how FDA plans assess products manufactured with advanced technologies as part of an initiative to reduce uncertainty for sponsors.

Manufacturing Regulation

Voluntary Limits On Antibacterial Discharges Increase As Fear Of Resistance Grows

Pharmaceutical companies are ratcheting up voluntary efforts to control discharges of antimicrobials from their plants and those of their active pharmaceutical ingredient suppliers so they won’t contribute to antimicrobial resistance. But will it be enough to fend off regulation in countries like India?

Manufacturing Compliance

Generics Firms Seek To Establish Better Conditions For Post-Approval Change Flexibility

Concerns raised around defining ICH Q12 “established conditions” for post-approval changes and potential role of prior knowledge for legacy products discussed in the context of generic drug applications; likely residual lack of harmonization explored.

Manufacturing Quality

Generics Firms Seek To Establish Better Conditions For Post-Approval Change Flexibility

Concerns raised around defining ICH Q12 “established conditions” for post-approval changes and potential role of prior knowledge for legacy products discussed in the context of generic drug applications; likely residual lack of harmonization explored.

Manufacturing Quality

How The US FDA’s Inspectional Approach Is Shifting For The Post-Pandemic Era

Agency hints of a “hybrid” future of in-person inspections supplemented by alternative tools like remote interactive evaluations.

Manufacturing Quality

Industry Fears Report-Writing Burden From Supply Chain Risk Guidance US FDA Is Drafting

As agency prepares guidance on CARES Act requirement for risk management plans to help prevent shortages of critical medicines, industry raised concerns that a broad interpretation of the “life-saving drugs” term used in the legislation could make compliance challenging.

Manufacturing Risk Management
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