Calyx RIM 7.0 Publishing

Folder Element Type Attributes

You can enter values for additional eCTD attributes in the following ICH eCTD M2-5 folders:

2.3.S Drug Substance - Substance, Manufacturer
2.3.P Drug Product - Product Name, Manufacturer, Dosage Form
2.7.3 Summary of Clinical Efficacy - Indication
3.2.S Drug Substance - Substance, Manufacturer
3.2.P Drug Product - Product Name, Manufacturer, Dosage Form
3.2.P.4 Excipients - Excipient Name
3.2.A.1 Facilities and Equipment - Manufacturer, Substance, Dosage Form, Product Name
3.2.A.2 Adventitious Agents - Manufacturer, Substance, Dosage Form, Product Name
5.3.5 Reports of Efficacy and Safety Studies - Indication

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Folder Element Type Attributes

You can enter values for additional eCTD attributes in the following ICH eCTD M2-5 folders:

2.3.S Drug Substance - Substance, Manufacturer
2.3.P Drug Product - Product Name, Manufacturer, Dosage Form
2.7.3 Summary of Clinical Efficacy - Indication
3.2.S Drug Substance - Substance, Manufacturer
3.2.P Drug Product - Product Name, Manufacturer, Dosage Form
3.2.P.4 Excipients - Excipient Name
3.2.A.1 Facilities and Equipment - Manufacturer, Substance, Dosage Form, Product Name
3.2.A.2 Adventitious Agents - Manufacturer, Substance, Dosage Form, Product Name
5.3.5 Reports of Efficacy and Safety Studies - Indication