The Ephedra Education Council has assembled a panel of researchers to study the supplement ingredient's safety profile in light of FDA's recent AER review, the industry group announces July 25. EEC charges FDA's approach to ephedra safety "has serious scientific limitations," echoing past comments by Metabolife and the General Accounting Office (1"The Tan Sheet" Aug. 9, 1999, p. 3). The council has asked FDA that the panel, chaired by Stephen Kimmel, MD, University of Pennsylvania, be permitted to present its findings at the Aug. 8 public meeting on ephedra (2"The Tan Sheet" June 12, In Brief). Metabolife is among the sponsors of a safety study conducted by Carol Boozer, St. Lukes-Roosevelt Hospital Center, New York City, who is evaluating data and will attend the public meeting
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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
