All NMEs and original BLAs are expected to adhere to the team-based review approach by the end of the year, with expansion to other application types later.
Sponsors should notice more widespread use of the integrated assessment concept within US Food and Drug Administration review divisions later this year, and potentially the growing pains that may come with it.
The integrated assessment is intended to encourage more collaboration among FDA assessors. The process includes the controversial combined review where...
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
