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Under a new category of generic ANDAs eligible for priority review, the FDA will prioritize applications likely to be ready for approval shortly after the six months of marketing exclusivity that is awarded to a first-to-file generic drug. Read More
FDA Commissioner Scott Gottlieb once again chastised brand-name companies that slow-walk federal procedures and use regulations to delay the entry of generic competitors. Read More
A group of investment funds sued Allergan, accusing the company of artificially inflating its stock by conspiring with other manufacturers of generic drugs. Read More
A Stanford law professor said the president already has the authority to provide for administration of unapproved drugs to military personnel — a power similar to that proposed for the Department of Defense in pending federal legislation that has raised alarms in Congress. Read More