In a report both boastful and defensive in tone, the agency explains why some disease areas are rife with targeted therapies while others have few or none.
Complaints about FDA regulatory requirements are not going to solve the underlying reason why some therapeutic areas lack targeted treatments, the agency says in a new report.
In "Targeted Drug Development: Why Are Many Diseases Lagging Behind?," the agency explains that shortfalls in the science, not FDA...
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.
