The MHRA is taking steps to embed “meaningful and impactful” patient involvement across its regulatory pathways.
The UK medicines agency, the MHRA, says it is planning to increase the role of patients in its scientific assessments by boosting their input at the pre-authorization stage, possibly in cases such as the submission of a new active substance, a new indication of an existing drug, or a combination product.
It is also proposing to boost patient input in cases where more information is needed, such as assessments for conditional...
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
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.
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.
