See Current Good Manufacturing Processes

cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
From Facts About Current Good Manufacturing Practices

See New Chemical Entity

A drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the act.
From Code of Federal Regulations, Section 21CFR314.108