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Pharmaceutical sciences / New Drug Application / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Biologic License Application / Investigational New Drug / Title 21 of the Code of Federal Regulations / Investigational Device Exemption / Food and Drug Administration / Medicine / Health
Pharmaceutical sciences
New Drug Application
Premarket approval
Federal Food
Drug
and Cosmetic Act
Center for Devices and Radiological Health
Biologic License Application
Investigational New Drug
Title 21 of the Code of Federal Regulations
Investigational Device Exemption
Food and Drug Administration
Medicine
Health

Guidance for Industry and FDA Staff:

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