3 Hrs Webinar on 505(b)(2) NDAs By Peggy J. Berry, (Ex FDA)
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes
Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 180 Min Live Webinar
"Hear By Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting "
What is a 505(b)(2)
NDAs submitted under FD & C 505(b)(2) are a submission for which it is
Not a generic nor is it a tratitional brand. However, as such a hybrid, it is a great sponsorship opportunity. Learn the requirements for studies, reference information and marketing requirements.
Why You should Attend The Session
NDAs submitted under section 505(b)(2) of the FD & C Act 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 benefit
- What is a 505(b)(2)
- What products qualify for submission under 505(b)(2) and which do not.
- Examples of data 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
- supply chain,
- technical operations,
- quality control,
- quality assurance,
- regulatory affairs
Industries who can attend
This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.