Pre-NDA Meetings Slated For Overhaul As Part Of New User Fee Cycle
BOSTON - The renewal of the user fee program will produce significant changes in how FDA and application sponsors approach their presubmission meetings, Office of New Drugs Deputy Director Sandra Kweder said
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Associate directors for safety and safety-regulatory program managers have begun their postmarket drug safety oversight roles within FDA's Office of New Drugs' 17 drug review divisions
ATLANTA - An agency-wide initiative to implement Good Review Management Principles at the Center for Drug Evaluation and Research should lead to more first-cycle reviews, CDER Associate Director of Regulatory Affairs Kim Colangelo said at a June 18 session of the Drug Information Association annual meeting
Drug makers need to continue investing in early-stage research to unveil the next $1 billion-plus drug, panelists at the Argyle conference agree.