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Food and Drug Administration / Pharmaceutical industry / Clinical Data Management / Drug safety / Common Technical Document / New Drug Application / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Drug Master File / Center for Biologics Evaluation and Research / Clinical research / Research / Medicine
Food and Drug Administration
Pharmaceutical industry
Clinical Data Management
Drug safety
Common Technical Document
New Drug Application
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Drug Master File
Center for Biologics Evaluation and Research
Clinical research
Research
Medicine

Guidance for Industry Submitting Marketing Applications According to the ICH-CTD Format — General Considerations DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

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