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Joanne Eglovitch

Joanne Serpick Eglovitch is a senior editor for “The Gold 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 Eglovitch

FDA Investigators Want Top Management Involved In Manufacturing Inspections

FDA’s expectation is that the most responsible individual at manufacturing sites be involved in inspections. The agency is increasingly talking about its “responsible corporate official” or Park Doctrine powers to hold top officials responsible for manufacturing issues and problems.

US States Manufacturing

FDA's First 90-Day Letters To Deliver Inspection Outcomes After Jan. 1

Happy New Year – or not! Firms inspected by US FDA since Oct. 1 will receive word within 90 days whether their facilities received passing – or failing – grades under timelines mandated by GDUFA II and incorporated into the agency's new Concept of Operations agreement, FDA officials tell FDLI meeting.

Manufacturing Quality

ICH Experts Aim To Set Elemental Impurity Exposure Limits For Topical Drug Products

ICH expert working group is encountering challenges in setting permitted daily exposure limits for elemental impurities in topical drugs, the group's rapporteur says. Nevertheless, the group is forging ahead and plans to have a Step 2 draft document ready for public consultation in May.

Manufacturing Quality

IGDRP Active Substance Review Guide Could Help Regulators – And Applicants

A group of regulatory authorities has published guidance for harmonizing members' reviews of active substances in drug applications so that it could be adapted for regulatory convergence worldwide – and so that generic drug firms could use it to anticipate regulatory expectations.

Drug Review Generic Drugs

US FDA Issues Long-Awaited DSCSA Grandfathering Guidance

Pharmaceutical manufacturers finally have some clarity on how and when un-serialized drug products can be grandfathered under DSCSA.

Manufacturing Quality

FDA’s Delay Issuing DSCSA Grandfathering Guidance Creating Problems For Manufacturers

US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.

Manufacturing Quality
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