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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

FDA Shifts On Measuring Daily Limits For Excipients From Potency To Maximum Exposure

International Pharmaceutical Excipients Council of the Americas supports the maximum daily exposure limit but suggests FDA retain potency limit field until it finishes adding MDE information to avoid causing confusion.

OTC Drugs Standards

RFID Tags Found To Improve Drug Supply Chain Tracking In Recent DSCSA Pilot

A pilot that used RFID tags with 2D barcodes was touted as more effective than using 2D barcodes alone in tracking drugs through the supply chain.

Manufacturing Quality

New Exposure Limits For Excipients Applauded

The US FDA has launched the second phase of an effort to improve its inactive ingredients database by replacing confusing potency amounts with maximum daily exposure limits, a change sought by generic drug and excipient manufacturers.

Manufacturing Quality

US FDA 'Bulks Up' 503B Outsourcing Drug List By Proposing Four First-Time Additions

The US FDA has proposed allowing outsourcing facilities to compound from four drug substances, but not from 19 others that it says already are available in FDA-approved drug products. Compounding pharmacies also would be allowed to compound from two of the four drug substances.

Manufacturing Quality

New Exposure Limits For Excipients Applauded While Loss Of Old Potency Limits Bemoaned

The US FDA has launched the second phase of an effort to improve its inactive ingredients database by replacing confusing potency amounts with maximum daily exposure limits, a change sought by generic drug and excipient manufactures.

Manufacturing Quality

US FDA Allows Simpler Approach To Expire Dating When Repackaging Drugs Into Unit Doses

The US FDA will not enforce expiration dating requirements for unit-dose repackaging if repackagers follow an alternative approach outlined in final guidance.

Manufacturing Quality
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