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Office of Generic Drugs (OGD) Directors Update Kathleen UHF, MD Director, Office of Generic Drug CDR/FDA GPA Annual Meeting February 23, 20161Disclaimer This presentation reflects the views of the
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The Director Office of Generic is a regulatory body that oversees the approval and monitoring of generic pharmaceutical products.
Manufacturers of generic pharmaceutical products are required to file with the Director Office of Generic.
The Director Office of Generic filing process involves submitting detailed information about the generic pharmaceutical product, including ingredients, manufacturing process, and testing results.
The purpose of the Director Office of Generic is to ensure the safety, efficacy, and quality of generic pharmaceutical products available in the market.
Information such as active ingredients, dosage form, strength, labeling, packaging, and bioequivalence data must be reported on the Director Office of Generic.
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