FDA Law Blog: Biosimilars

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

Labelling 44

Labelling 44

European Pharmaceutical Review

DECEMBER 20, 2023

Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). analysis (Source: L.E.K) By contrast, orphan drugs could become less profitable, more risky investments.

Biosimilars 98

Biosimilars Labelling Documentation 98

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 20 Good manufacturing practice (GMP) Commission Directive (EU) 2017/1572 (which supplemented Directive 2001/83/EC) lays out the principles and guidelines of GMP in the EU. 2012/1916).

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103