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FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

The FDA Law Blog

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g.,

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SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

ISPE

3M explores New Label-As-A-Service Concept with Blockchain on Azure to Stop Counterfeit Pharmaceuticals.” Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on. 5 (2003): 395–413.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. Table 2: Organization and labeling examples for environmental sustainability issues. 33 Fixtures and fittings with a WaterSense label, can achieve a 20% reduction in indoor water use.

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Two drug-related deaths reported on eve of Phase 3 lecanemab data

pharmaphorum

However, Science Magazine and STAT have reported two different patient deaths in the trial, based on not-yet-public adverse event reports and interviews with people familiar with the trial. STAT reported last month that a male patient died in June of a cerebral haemorrhage after taking the drug along with the common anticoagulant Eliquis.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

The original molecular weight (MW) specification for polypropylene glycol 2000 (PPG) of 1800–2200 was based on the Food Chemical Codex monograph (90%–110% of label) and not based on a scientific understanding of the process/product requirements. You may unsubscribe from these ISPE communications at any time. Company Name.