Roche’s Gazyva Clears FDA, But First Breakthrough Approval Breaks No Speed Barriers
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA cleared Roche’s Rituxan follow-on GA101 in roughly six months, the same amount of time as an old-school priority review.
You may also be interested in...
US FDA Biosimilars Staff Faces More Transition As Sue Lim Departs After Christl
Sue Lim, who serves as director of scientific review staff of the US FDA's Therapeutic Biologics and Biosimilars Staff, will be leaving the agency at the end of February to start an independent consulting firm.
A “Breakthrough” Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics
FDA’s much-anticipated guidance on expedited programs for drug development fills in some blanks on the new breakthrough designation, but simply advising sponsors they will need to pick up the pace on manufacturing plans and development of companion diagnostics leaves aspiring applicants wanting more, stakeholders said at DIA.
CDER Approvals In January Came Early And Often
FDA started 2012 with a bang: five novel approvals in January, including two of the fastest approval times in modern agency history (and the fastest therapeutic approval outside of oncology), plus two big decisions on anti-diabetics.