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As the FDA ramps up its preparations for renewing PDUFA, industry and related groups are pushing for a greater focus on patient perspectives in its next iteration. Read More
Drugmakers and trade groups overwhelmingly want lower user fees and a clearer review process for GDUFA as the FDA looks to renew the user fees before the Sept. 30, 2017 cut-off date. Read More
Xellia Pharmaceuticals and the FDA have agreed on a modified consent decree so Xellia can resume manufacturing at the Bedford, Ohio, site it purchased from Ben Venue Laboratories. Read More
Public Citizen is suing the FDA for withholding details about members of its advisory committees and panels, contending that this information could expose potentially problematic relationships with industry. Read More
The FDA has extended the PDUFA date of Dynavax’s investigational hepatitis B vaccine Heplisav-B by three months to review new data in the company’s resubmitted BLA. Read More