HHS Secretary Sebelius’ override appears to set a precedent of HHS intervention in an FDA product review.
Health and Human Services Secretary Kathleen Sebelius overruled FDA and denied Teva Pharmaceutical Industries Ltd.’s request to make the Plan B One-Step emergency contraceptive available OTC.
Sebelius’ override appears to set a precedent of HHS injecting in an FDA product review, although accusations of White House-level...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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
