Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

This interactive course will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.

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Session 16: The NDA Labels

Session Chair(s)

Priya Jambhekar

President

PBS Regulatroy Consulting Group, United States

The NDA Labels
Immediate Container Label
Carton Label
Small group exercise

Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

Session 16: The NDA Labels

Session Chair(s)

Priya Jambhekar

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