Negotiations for generic drug user fee reauthorization open with FDA saying it doesn't want a large number of small tweaks that will increase program complexity.
FDA wants to make significant, but feasible, changes to the generic drug user fee program as part of its reauthorization rather than too many small tweaks.
Agency officials told industry representatives during the first GDUFA II negotiating session that multiple small changes likely would complicate program...
Insurance trade groups warned that the Big Beautiful Bill destabilize Medicaid and result in the largest ever roll-back in health care coverage in the US.
Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.
Final guidelines explaining how staff at Canada’s Patented Medicine Prices Review Board should go about identifying drugs that could be considered for an excessive price hearing will come into force soon.
