CMC Submission definition
CMC Submission means a dossier containing all chemistry, manufacturing and controls information filed by Supernus or its sub-licensees to the FDA and other Regulatory Authority to support a filing for Regulatory Approval, as set forth in 21 C.F.R.
CMC Submission means a dossier containing all chemistry, manufacturing and controls information filed by Supernus or its sub-licensees to the FDA and other Regulatory Authority to support a filing for Regulatory Approval, as set forth in 21 C.F.R. § 314.50.