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The FDA is proposing annual dues for sponsors of one or more approved ANDAs to guarantee a more predictable stream of funding that will raise revenues for the agency’s generics program starting in fiscal 2018. Read More
Pfizer says it plans to begin sales of a biosimilar version of Remicade in late November, despite Janssen’s appeal of a ruling that invalidated its patent covering the arthritis therapy. Read More
Akorn Pharmaceuticals continued drug production when equipment malfunctions would normally require it to abort the batch, the FDA said in a Form 483. Read More