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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

US FDA And OMB Should ‘Pause’ Billion-Dollar Quality Metrics Program, Industry Groups Say

High projected cost and low perceived benefit merits further dialogue on US FDA's quality metrics initiative, industry coalition says. One group might tap into Trump administration's anti-regulatory view in advising budget office that compliance could cost industry $1bn per year. Groups question whether initiative could wind up causing drug shortages instead of preventing them.

United States Manufacturing

It’s Time To ‘Get Moving’ To Meet ICH Q3D Deadline, Industry Told

A pharmaceutical industry official said while it is not too late, manufacturers that have not yet started risk assessments to comply with ICH Q3D for legacy products need to get busy. Official also advised that good risk assessments should make it easier to comply and reduce the need to retest products if new metals are introduced into the manufacturing process.

Manufacturing Quality

US FDA Pushing For Generic Alternatives To Long-Acting Injectables, Implants

Complexity of manufacturing process for long-acting polymer-based injectable drugs, implants and in situ forming gels is delaying development of generic alternatives, but the US FDA hopes that new research into the formulation of these drugs will shed some light on how manufacturing processes can be replicated.

Manufacturing Generic Drugs

Quality Regulatory Updates In Brief: EMA, FDA, EDQM And WHO

EMA proposes updating methods for water for injection; FDA clarifies policies on first responders under new drug tracing law; EDQM lists top 10 API deficiencies; and WHO invites API manufacturers to participate in prequalification program.

Manufacturing Quality

US FDA Manufacturing Enforcement In Brief: Recent Warning Letters And Import Alerts

Recent US FDA drug GMP warning letters featured findings of lax contamination controls and data integrity issues at firms in China, India, Japan, Illinois and East Texas. Meanwhile, FDA hit six plants in India and China with drug GMP import alerts.

Manufacturing Quality

FDA Urges Full Participation In Quality Metrics Program

Despite the voluntary nature of US FDA’s program, an agency official urges full participation. Without data from such participation, FDA will not be able to predict drug shortages and industry will not see the benefits of reduced inspections and streamlined change control.

Manufacturing Quality
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