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Joanne S. Eglovitch

Senior Editor

Washington DC
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 S. Eglovitch

API Makers Must Control Dangerous Impurities Better, FDA Compliance Official Says

The compliance chief for FDA’s center for drugs said API makers need to do a better job of testing their products for impurities to avoid exposing patients to safety risks, as has occurred with at least one supplier’s valsartan API.

Manufacturing Quality

FDA Approving Complex Generics Pre-ANDA Meeting Requests At Higher Rates

Approval rates for complex-drug pre-ANDA meeting requests are climbing. FDA’s hope is that the meetings will hasten approvals of these hard-to-manufacture generics, which could put a dent in US healthcare costs.
United States Manufacturing

FDA Urges Development Of Generic Alternatives To Bring Down Prices Of Complex Drugs

Given the pressing need for more affordable versions of complex drug products like peptides, liposomes, transdermals and metered dose inhalers, FDA is encouraging generic drug companies to submit more applications for generic alternatives. FDA encourages industry to leverage agency-sponsored research for more advice on how to submit applications that will get approved.
Generic Drugs Quality

FDA Guidance On Post-Approval Changes for Drug Substances Closes Regulatory Gap

FDA’s guidance on post-approval changes for drug substances fills in some of the missing pieces of the regulatory puzzle on how these changes are to be reported and documented. And it arrives just as FDA and other regulatory authorities are talking with industry about major upgrades to post-approval changes processes proposed in the International Council on Harmonization’s draft Q12 guideline.
Manufacturing Quality

FDA Aims For Transparency In Releasing New Risk-Based Site Selection Model For Determining Who Is Inspected Next

US FDA explains new risk-based model for selecting manufacturing sites for inspection in US and abroad. By releasing information about the model, FDA aims to shed some transparency in its decision-making process. 
Manufacturing Regulation

Industry Groups Seek Clarity On FDA's Draft Waiver Guidance Under DSCSA

Pharmaceutical industry groups want more direction on how non-direct trading partners will be notified that a drug has been granted a waiver, exception or exemption (WEE) request under DSCSA so that good product is not deemed suspect and thrown out. There were also calls to expand the list of drugs eligible for exemption to include temperature-sensitive drugs as well as orphan drugs.

United States Manufacturing
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