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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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Revised Annex 1 now effective

European Pharmaceutical Review

As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. What is included in the new revision?

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Newsletter – November 2023

Fuld & Company Blog

Each article provides a concise, strategic viewpoint designed to inform and guide your business decisions. Practicing War Games at UC Irvine’s business school AI is transforming the private equity deal lifecycle, from document review to data analysis.

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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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Episode 864: Why Did ISMP Remove the Do Not Crush List from Their Website?

Pharmacy Joe

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage 111
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EMA revises guidance on nitrosamine impurities

European Pharmaceutical Review

As of 7 July 2023, the European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities. Evaluation of Ames assay test conditions for N -nitrosamines is ongoing, with a goal to identify the most robust Ames testing conditions, EMA reported in the revision document.

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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

These standardised documents provide meticulously curated and scientifically approved information. 11 This requirement directly contradicts what is included in Article 63. References European Commission, (26 April 2023). Article 63 EMA (29 January 2020). Euractiv (6 October 2023). Article 63 PGEU (2023).