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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

Pharmaceutical Groups Urge FDA To Upgrade From NDC To GTIN To Avoid Conflicts With DSCSA

Pharmaceutical manufacturers and distributors complain that FDA’s plan to add digits to the NDC would be a mistake and could potentially conflict with global standards as well as the bar code technology systems put into place under the Drug Supply Chain Security Act. They suggest embedding the NDC into the GS1 Global Trade Identification number (GTIN) to avoid these conflicts.
Manufacturing Distribution

Public/Private Cooperation, Tailored Assistance Deemed Key To Enhancing Quality Of US Drug Imports

Public health experts tell committee that much work lies ahead in strengthening the regulatory systems of low-and middle-income countries, and recommend ways to bolster these systems and improve the quality of imports.
Quality Manufacturing

PIC/S Guideline Sets Harmonized Approach For Classifying GMP Deficiencies Worldwide

PIC/S has issued guidance to help member pharmaceutical inspectorates classify good manufacturing practice deficiencies to ensure there is a consistent view across inspectorates as to which deficiencies are “critical” or “major.”

Asia Pacific Europe

FDA Ups Pressure On Stem Cell Therapy Makers To Follow Product Approval Rules

US FDA is frustrated that few stem cell therapy makers are seeking regulatory approval of their products during the current enforcement grace period. 
United States Manufacturing

Industry Group Advises Manufacturers On Quantifying Risks of Raw Materials Used In Advanced Therapy Medicinal Products

A concept paper prepared by an EU industry group is designed to help manufacturers conduct risk assessment for raw materials used in advanced therapy medicinal products (ATMPs) and biopharmaceutical products.
Europe Manufacturing

Pharmaceutical Manufacturers Testing Use of Verification Router Services To Process Saleable Returns Under DSCSA

Pharmaceutical manufacturers, distributors and wholesalers are piloting the use of verification router service (VRS) systems to comply with a looming deadline under DSCSA requiring them to establish systems for verifying saleable returns. Yet there are still many unanswered questions on how these systems will work.
Manufacturing Quality
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