Revised draft guidance suggests greater openness to alternative methods and scales for measuring adhesion, but agency sticks with 15% non-inferiority margin despite manufacturer objections; FDA also releases new guidance on assessing irritation and sensitization potential with topical delivery system products.
The US FDA’s revised guidance on assessing adhesion with transdermal and topical delivery system (TDS) generic drugs reflects the agency’s receptivity to some, but not, all of industry’s criticisms that a June 2016 draft document would be too burdensome for manufacturers.
A revised draft guidance released Oct. 9 suggests a greater openness to the use of alternative methods and scales...
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.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
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.
