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For the next generation of the FDA’s biosimilar user fee program, the agency is proposing a new model for reviewing 351(k) applications — allowing for additional communication between review teams and sponsors through development meetings across the submission timeline. Read More
An appropriations bill that would provide $5.2 billion for the FDA in fiscal 2018 got the nod from a House subcommittee Wednesday, bucking the White House’s spending request and giving the agency a slight spending increase for next year. Read More
The FDA surpassed many of its performance goals for generic drug applications through 2016, but the agency needs a plan for the user fees collected but not spent in the same year, according to the GAO. Read More
The FDA implemented a new policy to expedite generic drug reviews in areas of limited competition, and published a list of off-patent branded drugs with no approved alternatives, as the first steps in the agency’s action plan to help lower the costs of prescription drugs. Read More
The European Medicines Agency published a step-by-step guide for drugmakers to prepare for the implementation of the new EudraVigilance adverse event monitoring system, scheduled for Nov. 22. Read More