User Fee Program Renewal Gets Trickier After Ruling In Omnitrope Court Case
Renewal of FDA's Prescription Drug User Fee Act could be complicated by a federal court ruling that the agency must take action on Sandoz' application for a follow-on version of Pfizer's recombinant human growth hormone Genotropin
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The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges