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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

As COVID-19 Response Capacity Loans Languish, DFC Punts GAO’s Questions About It To DOD, HHS

Loan program launched in June 2020 to strengthen domestic supply chains for COVID-19 response was deluged with applications, but has not completed any loans, and the GAO has a good idea why.

Coronavirus COVID-19 Manufacturing

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?

Outlook 2022 International

Resiliency Roadmap Update: US FDA Exceeds FY 2021 Inspection Projections

While better than one its ‘best case’ scenarios, FDA has completed just 31% of 15,514 domestic surveillance inspections planned for FY 2021, applications are still being delayed, and foreign inspections have for the most part yet to be tackled.

Manufacturing Quality

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
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