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Joanne S. Eglovitch

Senior Editor

Washington DC
Joanne Serpick Eglovitch is a senior editor for Pink Sheet where she writes about manufacturing quality issues. Joanne has over 20 years of experience covering the regulated pharmaceutical and medical device industries, and helped launch the “International Pharmaceutical Regulatory Monitor” and the “International Medical Device Regulatory Monitor”. Previously Joanne covered the mortgage finance industry and the mortgage capital markets, and employment and training programs. Before her forays into newsletter journalism, Joanne worked as a general assignment reporter for a twice-weekly newspaper in southern Maryland and an editorial assistant for “Insight” Magazine, published by “The Washington Times.”

Latest From Joanne S. Eglovitch

Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others

Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”

Manufacturing Quality

EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns

Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.

Manufacturing Quality

US FDA Mulls Advance Notice On Domestic Surveillance Inspections Post-COVID

Criticized for giving foreign sites advance notice of inspections, agency is considering giving such notice to domestic sites too even after surprise inspections become possible.

FDA Manufacturing

US FDA Mulls Possibility Of Preannouncing Post-COVID Domestic Surveillance Inspections

Criticized for giving foreign sites advance notice of inspections, agency is considering giving such notice to domestic sites too even after surprise inspections become possible.

Manufacturing Quality

FDA Relying More On Predictive Analytics To Help Monitor Quality Risks Of Sites During Pandemic

Analytics tool plays key role in helping agency oversee quality of 1,800 newly registered hand sanitizer facilities despite travel restrictions.

Manufacturing Quality

Legislators Clamor For More Surprise FDA Inspections Abroad

House lawmakers who get the first cut at setting the FDA’s budget joined GAO expert in raising concerns about shortage of investigators and lack of surprise for foreign inspections.

Manufacturing Quality
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