CMC

CMC. Chemistry, manufacture and control.

CMC. Chemistry manufacturing and control information required by the FDA for filing of an IND or NDA

CMC. Chemistry, manufacturing and controls information.

CMC. Means (i) manufacturing process development for all presentations of Product; (ii) all chemistry, manufacturing and control procedures necessary for the manufacturing, testing and quality control release of all presentations of the Product; and (iii) sourcing and testing of all raw materials and components used in the production of all presentations of the applicable Product.

CMC. Chemistry Manufacturing and Controls.

CMC. With respect to a Product, the information contained in (or that would be contained in) the chemistry, manufacturing and controls section of an IND or application for Regulatory Approval for such Product in the United States, or the equivalent section of corresponding regulatory filings made outside the United States. For the avoidance of doubt, the information described in the preceding sentence is CMC information regardless of what document it is contained in or the form in which it is... disclosed. View More

CMC. Shall mean the chemistry, manufacturing, and controls section(s) and data in any Health Registration(s) that covers the chemical composition of a given Product and its components and the control and Manufacturing Procedure for any Products and their components, as may be amended or supplemented from time to time.