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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

US FDA Mulls Pilot To Examine Separate Review Pathway For Novel Excipients

Proposal could yield a bounty of new options for innovative drug delivery systems.

Manufacturing Quality

US FDA Says Data Integrity Remains Challenging For API Manufacturers

Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.

Manufacturing Quality

US FDA Suggests Using ICH Drug Guidance To Meet Device Quality Requirements for Transdermals

FDA’s draft guidance on transdermal and topical delivery systems says manufacturers can leverage pharmaceutical development studies principles for device design control requirements.

Manufacturing Quality

Industry Not Sold On FDA Emerging Technology Program

FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at a recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.

Manufacturing Quality

Generic Industry Not Sold On Benefits Of FDA Emerging Technology Program

FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.

Manufacturing Quality

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
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