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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.”
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Latest From Joanne S. Eglovitch

ANDA Sponsors Should Ask DMF Holders About 'Hidden Facilities'

FDA says 16% of ANDAs have an issue with "hidden facilities" that are listed in drug master files but not the ANDAs they are linked with; industry official offers some tips to bridge this communications gap with DMF holders.

Manufacturing Regulation

ANDA Sponsors Urged To Ask DMF Holders About 'Hidden Facilities'

FDA says 16% of ANDAs have an issue with "hidden facilities" that are listed in drug master files but not the ANDAs they are linked with; industry official offers some tips to bridge this communications gap with DMF holders.

Manufacturing Quality

FDA’s OPQ Chief Tells Generic Drug Makers Its Time To Up Their Quality Game

The head of US FDA’s drug quality office comments on quality-related topics at the GRx-Biosims meeting; sheds more light on facility rating system plan.

Manufacturing Quality

First-Time OTC Facility Inspections Drove US FDA Warning Letter Surge In FY 2019

The good news: 75% of firms not previously inspected were in compliance with US drug GMP requirements; the bad news, 25% weren't. CDER Office of Manufacturing Quality director Francis Godwin says FDA remains concerned about vulnerabilities in supply chain when OTC firms don't test products for impurities that have harmed and killed consumers in the past.

OTC Drugs FDA

First-Ever OTC Inspections Drove Surge Of FDA Warning Letters In FY 2019

The good news: 75% of never-before-inspected firms complied with US drug GMP requirements. The bad news: 25% did not.

Manufacturing Quality

Drug Makers Have Exceeded Expectations In Implementing DSCSA Serialization

A new barcode assessment study finds the US pharmaceutical industry has come a long way in serializing drug products over the past several years. 

Manufacturing Quality
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