Generics in Brief
This article was originally published in The Gold Sheet
FDA’s new generics leader; the latest on QbD requirements for ANDAs; and the value of QC method patents
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A new guidance includes preliminary estimates of backlog, application and drug master file fees under the new generic drug user fee program. However, the agency must wait for Congress to pass an FY 2013 appropriations bill or continuing resolution with language allowing it to collect the new revenue.
In a dispute related to Amphastar/Watson’s generic enoxaparin, a Federal Circuit panel takes an expansive view of the “Bolar Amendment” and finds that certain post-approval activities are protected from infringement claims, including quality control batch testing of commercial product. The decision draws a blistering dissent from the appeals court’s chief judge, who warns the ruling will “render manufacturing method patents worthless.”
Gregory Geba mostly has brand experience, but will be expected to lead OGD’s reorganization as it implements a new user fee program.