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).
Topics
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
Who should Attend
Supply Chain
Manufacturing
Quality Control
Technical Operations
Regulatory Affairs
Quality Assurance
Past Events
505(b)(2) NDAs 2019 - 27 Feb 2019, Webinar (82501)
Important
Please, check "505(b)(2) NDAs" official website for possible changes, before making any traveling arrangements
