OGD will accept ICH recommended long-term stability temperature and humidity conditions data.
ICH-RECOMMENDED LONG-TERM STABILITY CONDITIONS FOR ANDA PRODUCTS will be accepted by FDA's Office of Generic Drugs, OGD states in an Aug. 18 letter to generic pharmaceutical companies. ANDA applicants may submit long-term stability data conducted under the room temperature and relative humidity recommended by either the International Conference on Harmonization or current FDA standards.
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