Drug Repositioning and the 505(b)(2) Application: A Step-by-Step Approach to a Fuller, More Profitable Pipeline
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You can save millions of dollars and valuable time, but you'd better know every nuance of the 505(b)(2) application. If you think you can apply the same knowledge you use for 505(b)(1) or (505)(j) ANDA, you're wrong — and that can cost you big time!
Don't even take the first step of processing a 505(b)(2) without attending this 90-minute Encore presentation!
Listen closely while Kenneth Phelps, president and CEO of Camargo Pharmaceutical Services, compares the various new drug approval applications and shows you when a 505(b)(2) is the best choice. He will provide a submission process that has been proven successful in many applications and describe the pain points of the 505(b)(2) application and how to best deal with them. Kenneth will show where your company's focus should be and the resources to allocate along the way. Finally, he will explain the impact the new PDUFA/FDA Amendments Act will have on 505(b)(2) applications.
Sign up your entire team to listen in and discover:
- The first step — feasibility assessment
- Three objectives
- The main goal of the assessment
- The regulatory pitfalls to expect and plan for
- The pre-IND meeting
- What the FDA will be looking for
- How to get acceptance of the 505(b)(2) pathway
- Proposed clinical and product development plans
- Preclinical testing
- Expectations
- Acceptable tests
- How to know when you've succeeded or failed
- Phases I, II and III testing
- What will be required and when
- The proper timelines to ensure accuracy and profitability
- Other product development tasks that should be completed during this time
- The five modules of the 505(b)(2) submission
- The information that should be in each
- The two most important modules to understand
- What to do if the information is either incomplete or not ready
- Labeling and naming considerations to meet FDA expectations
Sign up today and have a thorough understanding of the process to file a 505(b)(2) application. Plus, you'll get a chance to ask your toughest questions during the Q&A session.