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Communication

Labelling

Magazine

FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

FDA Law Blog: Biosimilars

APRIL 25, 2024

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.,

Biosimilars

Biosimilars Labelling Communication

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

pharmaphorum

NOVEMBER 29, 2022

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.

Communication

Communication Labelling

Pharmacist Digest

FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

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

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