Tag: Idelvion

Idelvion

Regulatory/FDA

CBER’s APLB Issues First Enforcement Letter Since 2015 for Misleading Efficacy Claims

CBER’s APLB Issues First Enforcement Letter Since 2015 for Misleading Efficacy Claims

March 7, 2018 – The Center for Biologics Evaluation and Research’s (CBER’s) Advertising and Promotional Labeling Branch (APLB) may not exactly be an enforcement powerhouse, issuing just three Untitled Letters since 2013, but it found fault with CSL Behring LLC’s Website, patient brochure, exhibit panel and sales aid for IDELVION® because these promotional materials allegedly […]

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