USP data show fewer US drug shortages but longer ones, averaging 5+ years. Drug shortages are an incentive problem, not a manufacturing mystery.

Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.

In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.

Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how the company’s product is worth the investment by protecting products and patients.

The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.

Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how its connected technology can enhance anticounterfeiting and how data are handled within the product.

Celtic Renewables won the CPHI Award for Sustainable Pharma Excellence for its green chemicals used in pharmaceutical manufacturing. Bettina Brierley, chief commercial officer, talks about the adoption, capacity, and pricing of biosolvents.

Terry Katz, CEO and cofounder of ForgeStop Technology Corporation, explains the company’s CPHI Award-winning connected product technology and how it helps to combat drug counterfeiting.