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STAT+: NYU professors who defended vaping didn’t disclose ties to Juul, documents show

STAT

Abrams asked Juul officials for talking points, allowed company executives to review an academic article prior to publishing, and attended Juul scientific advisory board meetings, all without disclosing those connections to journal publishers or the public. Continue to STAT+ to read the full story…

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Top 10 Journal Articles To Read During Your Infectious Diseases Pharmacy Rotation

ID Stewardship

In this post a top 10 list of journal articles to read during an infectious diseases pharmacy rotation is provided. Articles included here are some of my favorites. Not being included in this list does not reflect a lack of quality and certainly there are many robust articles that could be added. Authored by: Timothy P.

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What Does the FDA's Recent Update of the Nitrosamine Guidance Convey?

PharmaTech

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

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Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average

Drug Patent Watch

This article was originally published by Hermann Mucke & Peter Mucke in Future Drug Discovery under a Attribution-NonCommercial-NoDerivatives 4.0 The post Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average appeared first on DrugPatentWatch - Make Better Decisions.

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Driving QbD as a quality standard in drug development

European Pharmaceutical Review

While advantages to the Quality by Design approach is clear and practical implementation of Quality by Design is encouraged by publication of public guidance documents ICH Q8(R2) – ICH Q14, the industry has not yet fully embraced the QbD approach in Marketing Authorisation Applications (MAAs) for European market approval, the authors noted.

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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog: Biosimilars

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

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How should cleaning validation sampling locations be chosen?

European Pharmaceutical Review

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.