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Good manufacturing pathway needed for FDA to consider new drug approvals
SAN FRANCISCO — Six ophthalmic new drug applications were stalled by the FDA in 2016 for issues with chemistry, manufacturing and controls. Without commenting specifically on drugs not approved, one member of the FDA did relate a trend that could potentially be a contributor to holding up the approval process: New drug applications are being submitted with limited pathways through good manufacturing procedures.Wiley Chambers, MD, speaking as an FDA panelist at the Glaucoma 360 New Horizons Forum, said, “We used to see applications be submitted with several proposed drug source (Read more...)