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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

US FDA And NIST Form Partnership To Boost Advanced Manufacturing Techniques

The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.

Manufacturing Quality

US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

Regenerative Medicine Manufacturing

2020 In Review: Despite Pandemic, The US FDA Issued Just 20% Fewer Drug GMP Warning Letters

The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.

Manufacturing Quality

US FDA Still “Actively” Drafting Proposed Licensing Rule For Wholesalers and 3PLs

Pharmaceutical manufacturers should have already begun serializing products and verifying saleable returns to comply with DSCSA, says FDA official who also asserted that licensing standards for wholesale distributors and third-party logistics providers will be forthcoming. This rule is already six years overdue under a DSCSA mandated timeline.

Manufacturing Quality

US FDA Calls For Drugmakers To Test Alcohol Ingredients For Methanol

The US FDA wants manufacturers and compounding facilities to test drug products for methanol in alcohol ingredients, and responds to reports of fatal methanol poisonings of consumers who ingested alcohol-based based hand sanitizers.

Manufacturing Quality

Firms That Get Complete Response Letters Might Get Inspected By US FDA Six Months After Replies

While COVID-19 continues to wreak havoc on FDA's ability to perform onsite preapproval inspections, new guidance offers some clarity, but the news isn't great for ANDA holders.

Manufacturing Complete Response Letters
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