505(b)(2) NDAs 2019 is an event dedicated to products that qualify for submissions under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C).
505(b)(2) NDAs 2019 covers topics such as:
- What products qualify for submission under 505(b)(2)
- What is a 505(b)(2) NDA
- Requirements for studies to be conducted
- Examples of data and information that may be referenced
- Limitations to and benefits of a 505(b)(2)
- Submission content requirements
505(b)(2) NDAs 2019 intended for:
- Supply Chain
- Manufacturing
- Quality Control
- Technical Operations
- Regulatory Affairs
- Quality Assurance
