Allergan's Freedom From Expression Suit Challenges Gov't REMS, Off-Label Powers
The firm wants to go beyond the REMS requirements and offer treatment guidance, not just risk information, about the use of Botox for spasticity, an unapproved condition.
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After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.