Day: September 3, 2026

Navigating the transition from drug approval to market substitution requires a clear understanding of how regulatory bodies evaluate therapeutic equivalence. The FDA’s latest guidance on the topic gives drug sponsors a transparent view into how the agency assigns Orange Book codes. Understanding these principles is vital for biopharma executives, regulatory teams, and commercial strategists looking … Read more

Navigating the clinical trial landscape requires balancing groundbreaking innovation with extreme financial burden, particularly when manufacturing costs threaten to stall development. The FDA offers a formal pathway to recover direct costs for investigational drugs and devices without triggering allegations of premature commercialization, whereby the sponsor can get FDA’s approval to charge for its investigational drugs … Read more