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Home » FDA Eyeing Major Changes to CMC Reviews for ANDAs
FDA Eyeing Major Changes to CMC Reviews for ANDAs
September 1, 2005
The FDA’s Office of Generic Drugs (OGD) has launched an initiative to revamp its chemistry, manufacturing and controls (CMC) review process for abbreviated new drug applications (ANDAs) — a project the agency said will improve application review times and reduce the number of CMC supplements that manufacturers must submit.