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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

Continuous Manufacturing Guidance From US FDA Aims For Wider Industry Adoption

Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’

Manufacturing Guidance Documents

ICH Q9 Revision Delayed By Three Months Due To COVID; Focus Spans Risk Assessments, Shortages

Extension will add training materials with goal of reducing quality defects and recalls. Revision process will also address shortage indicators related to production failures in an attempt to head off drug shortages.

Manufacturing Quality

Remote Methods Drove Most US FDA Enforcement Actions In FY 2021

Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over the past year – and may play key role post-pandemic.

Manufacturing Quality

Draft US FDA Guidance Outlines Heightened Expectations On Sterility Of Non-Sterile Drugs

More testing expected after B. cepacia contamination of OTC liquid drug products, including for Rx drug products.

Manufacturing Quality

US FDA Guidance On B. Cepacia Contamination Coming Soon, CDER Director Cavazzoni Says

Agency will provide guidance in wake of recent outbreaks of Burkholderia cepacia in non-sterile, water-based drug products.

Manufacturing Quality

CDER Pilot Program Offers Potential New Pathway For Approval Of Novel Pharmaceutical Excipients

After decades without an approval pathway for excipients, FDA pilot program paves the way for innovation.

Manufacturing Quality
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