FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from industry representatives for an alternative to FDA’s proposed America First fee incentive effort.
An advocacy group takes aim at FDA, arguing in a new report that the agency’s drug review process has grown more costly and restrictive.
FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from industry representatives for an alternative to FDA’s proposed America First fee incentive effort.
An advocacy group takes aim at FDA, arguing in a new report that the agency’s drug review process has grown more costly and restrictive.
USC associate professor Genevieve Kanter says she is skeptical that the wholesale firing of HHS advisory committee experts to eliminate industry influence will restore public trust in FDA and other agencies.
Health experts breakdown a new FDA policy framework that could mark a turning point for highly individualized genetic medicines.
