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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

US FDA Gives Industry An Extension On Nitrosamine Risk Assessments

Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.

Manufacturing Quality

How Genentech Pivoted To Digital During The Pandemic

Technologies like head-mounted tablets became critical for method transfers, virtual inspections and more. Cloud-based submissions could be next …

Manufacturing Quality

Industry Urged To Use ICH Q12 Protocols To Ease Post-Approval Changes For Analytical Methods

Post-approval change management protocols could go a long way toward smoothing global rollout of analytical method changes, ICH Q12 expert says.

Manufacturing Quality

Next-Generation Sequencing For Adventitious Virus Detection Helps Speed Response To COVID-19

It's another case where the pandemic spurs adoption of ways to speed the manufacture of vaccines and biologics that have been in development for years.

Coronavirus COVID-19 Manufacturing

US FDA To Share Remote Assessment Findings And Mull Replies Before Issuing Complete Responses

No more letters derailing applications over surprise drug GMP issues raised in remote records reviews, agency says. Now if sponsors get these CRLs, they will already know why.

Manufacturing Quality

US FDA And NIST Form Partnership To Boost Advanced Manufacturing Techniques

The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.

Manufacturing Quality
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