FDA’s Unapproved Drugs Policy Draws Legal, Regulatory Responses From Lannett, To Little Success
Executive Summary
Generic drug maker Lannett Co. is taking a two-pronged approach in responding to FDA’s unapproved drugs initiative, seeking regulatory approval of a previously unapproved opioid product while simultaneously suing the agency in federal court.
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Sept. 19, 2011: The Day FDA’s Discretion On Unapproved Drugs Stood Still
FDA is drawing a line in the sand when it comes to unapproved drugs, and that line begins at Sept. 19, 2011.
Sept. 19, 2011: The Day FDA’s Discretion On Unapproved Drugs Stood Still
FDA is drawing a line in the sand when it comes to unapproved drugs, and that line begins at Sept. 19, 2011.