Regulatory Affairs: The IND, NDA, and Post-Marketing
Learn about FDA regulations and expectations for the content, submission, and review of INDs/NDAs and the importance of regulatory strategy. This comprehensive course employs a blend of real-world and interactive lectures, workshops, and online pre-course modules. This basic to intermediate level training course focuses on prescription drugs and well-characterized biological products. The requirements specific to generic drugs, biosimilars, devices, and OTC monograph products are not covered in detail.
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Description
What You Will Learn
- Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes
- Preparation
- Content
- Maintenance and updates
- Strategy
- What to expect at meetings and in other interactions with FDA
- Regulatory Requirements for Prescription Drug Labeling and Advertising
- Post-Marketing Requirements