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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

FDA: Key FY 2019 Warning Letter Trend Is Inadequate Testing For API Impurities

This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.

Manufacturing Quality

The US FDA Acts To Bolster Adverse Event Reporting For Compounded Drugs

After discovering one firm suppressed over 4,000 compounded-hormone adverse event reports, agency leans on compounders and outsourcers to improve reporting.

Manufacturing Quality

GS1 Standard Would Speed The Sale Of Returned Drugs After November Deadline

New messaging standard from GS1 would enable industry to sell most returned drugs after November DSCSA deadline without running afoul of the FDA.

Distribution Manufacturing

The FDA Proposes Adding Five Of 31 Drug Substances To 503A Bulks List

FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.

 

Manufacturing Quality

NIIMBL Seeks Advanced Biopharma Manufacturing Proposals To Fund

The public-private partnership has $5.5m for grants to develop continuous manufacturing methods, cell/gene therapy platforms and other biopharmaceutical manufacturing innovations.

United States Manufacturing

Nine More FDA Bulk Compounding Denials Proposed Post-Vasopressin

Expected flurry of FDA proposals against 503B compounding from bulk drug substances follows vasopressin court ruling.

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