No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had an appeal of a designation decision 'under consideration' for 18 months and counting.
A new citizen petition is aiming to push the US FDA's Office of Combination Products (OCP) to establish timelines for appeals of designation decisions, citing "significant delays" in reviews and in challenges to designations of products with a drug or biological primary mode of action.
The petition dated March 3 does not name a sponsor, but was filed on behalf of a client...
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
