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Drugs and Health Products

Blood Products, Vaccines, Genetic Therapies & Diagnostics

Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format
Date: 2003-06-25

Guidance for Clinical Trial Sponsors: Clinical Trial Applications
Date: 2003-06-25

The Common Technical Document- ICH Topic M4
Date: 2003-06-25

Stability Testing of Existing Drug Substances and Products
Date: 2003-06-10

Help Notes
Date: 1998-05-15