Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Earlier this month, the US Food and Drug Administration (FDA) issued new draft guidance regarding their accelerated approval pathway for new drugs and biologics, an expedited program designed to help address unmet medical...more
In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more
PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more