US FDA Continues Reviewing Marketing Reports, Will It Punish Scofflaws?
Six months after submission deadline, about one-third of one-time marketing status reports have been reviewed, agency says.
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A firm will take ownership of US ANDAs from manufacturers unwilling to pay program fees or withdraw the approved generic drug application; is it a novel concept allowing future marketing options or simply fee avoidance?
Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.
With about 20,000 products eligible for US marketing status report on drugs in Orange Book, there is no timeline for all changes to be made.