In this webinar attendees will learn which products qualify for submissions under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) and the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship opportunity.
Why Should You Attend:
NDAs submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) are a those for which the product is not a generic nor a traditional brand. It allow sponsors to reference data that was not generated by them. This type of submission can shave years off of the development process and save millons of dollars. Attend this webinar to learn which products qualify for submissions under 505(b)(2), data that may be referenced, content requirements, and regulatory benefits.Areas Covered in the Webinar:
- What is a 505(b)(2) NDA
- What products qualify for submission under 505(b)(2)
- Examples of data and information that may be referenced
- Requirements for studies to be conducted
- Submission content requirements
- Limitations to and benefits of a 505(b)(2)
Who Will Benefit:
- Manufacturing
- Supply Chain
- Technical Operations
- Quality Control
- Quality Assurance
- Regulatory Affairs
Speaker
Peggy BerryCourse Provider
Peggy Berry,
