Generic Biologics Timing Depends On FDA Commissioner, Barr Says
This article was originally published in The Pink Sheet Daily
The products could be on the market within three years if an FDA commissioner of former chief McClellan's "disposition" is confirmed, CEO Downey says. The process could take longer if the confirmed commissioner is more "reticent to change."
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Barr agreement with Pliva marks the generic drug marketer's second move into generic biologics, with the company aiming to become an early leader in the field. Barr will be responsible for regulatory work to establish a pathway for approval of G-CSF.
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