EMA
A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.
EU drug regulators are taking steps to strengthen their assessment capacity by widening access to specialists from outside the EU/EEA.
The European Medicines Agency says it is speeding up its review of drug marketing applications through initiatives that restrict requests from companies for additional response time and minimize unnecessary questions from the assessors.
Finalized EU pharmaceutical legislation must ensure that patients are fairly represented in regulatory decision making, according to patient and industry experts.
US FDA
The soon-to-be former CDER director will return to the oncology office to complete his FDA tenure, the agency said.
In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.
Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.
Flu vaccines are specifically mentioned in the CBER director's internal email, but all new and some older vaccines seem to be affected. The impact on development programs is unclear.