Remove Compounding Pharmacies Remove Documentation Remove Labelling
article thumbnail

FDA accepts Outlook Therapeutics’ BLA for wet AMD treatment

Pharmaceutical Technology

On receiving approval, the treatment is expected to replace the requirement to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for wet AMD treatment. It is also developing registration documents for approvals in Europe, with submission expected in the fourth quarter of this year.

article thumbnail

Supplier qualification standard aims to strengthen supply chains for quality medicines, dietary supplements, and foods

Quality Matters

While focuses on evaluating and establishing supplier reliability for pharmaceutical manufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients.