07.07.22 -- FDA Publishes Guidance For Biopharma Container & Carton Label Design

The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.

As therapeutics become increasingly complex, so does the challenge of assessing potential risks associated with the chemical composition of materials used for drug packaging. The importance of tackling this hurdle — and doing so early in development — can’t be overstated.