Complying With the DSCSA

As drug development increasingly targets multiple indications, pharma companies must make strategic branding decisions—balancing regulatory requirements, market dynamics, and patient safety—to choose between single-brand or multi-brand approaches.

Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drug pricing and market access.

Though this specific agreement centers around aerospace and automobiles, the greater supply chain will wait and see how Trump’s import taxes impact pharmaceuticals, a sector that faces a potential 25% tax on imports.

Claire Riches highlights inefficiencies in the current drug approval process, while outlining the role of payers and insurers in shifting toward data-driven approval framework.

In order to succeed in today’s outcomes-driven healthcare landscape, pharmaceutical companies must move from traditional sales models to strategic, measurable partnerships with integrated delivery networks (IDNs).

The designation allows pharmacists to substitute it for Humira without prescriber approval (per state law), which expands patient access in the process.