Newly added signatories include Alcon, Astellas, BeOne, BridgeBio, CSL, Kyowa Kirin, Sun, Teva, and UCB, spanning hemophilia, ...
Recognize the role human factors expertise, onboarding, and training and education play in building patient confidence and supporting long-term adherence. Joe Reynolds, Head of User Experience ...
Direct-to-consumer drug marketing signals high-value, high-velocity targets, driving theft and diversion of GLP-1s and other ...
That risk is why Ali argues readiness has to happen years ahead of the effective date, not at the deadline itself, with real testing built in well before Day One. Waiting to find out whether systems ...
Cencora's Gregg Gorniak on where DSCSA trading partners find shared value in compliance investment, and where that alignment breaks down. DSCSA compliance investments only create value when trading ...
The biosimilar market is smaller but rapidly expanding. As more blockbuster biologics lose exclusivity across immunology, ...
Of the seven principles set out in the Council for International Organizations of Medical Sciences Working Group (CIOMS) ...
Nine more manufacturers join the MFN program, pairing new Medicaid pricing deals with $19.6B in U.S. manufacturing investment ...
HDA's Kala Shankle says a two-year national licensure runway for distributors could work, but only if states, the FDA and industry move in parallel. A proposed two-year implementation window may sound ...
Most-Favored-Nation rhetoric and international reference proposals can become practical anchors despite unclear ...
Cencora's Gregg Gorniak breaks down what separates basic DSCSA compliance from using it to streamline transactions and strengthen trading partnerships. Meeting DSCSA's letter and building genuine ...
McKesson's Scott Mooney discusses the technical and operational challenges of DSCSA compliance, from linking ERP systems to ...