Webinars >>FDA Regulations
 How to Increase the Odds for Success of Your 505(b)(2) Product​ 

Common problems with developing 505(b)(2) products are lack of a robust development plan, manufacturing and formulation issues, and over-committing non-clinical studies. A 505(b)2) product is an improved or altered version or a new use of a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. However, if poorly executed, a 505(b)(2) program can quickly turn into the nightmare scenario of uncontrolled and delayed time-line, budget overruns, and failed studies. Ideally, the 505(b)(2) drug should be able to piggyback on most of the available information for the reference drug and minimize new non-clinical and clinical studies, and expensive time-consuming manufacturing processes. However, if not executed optimally, the 505(b)(2) program can quickly turn into a longer than expected program, reducing the return on investment and frustration. 

Like all drug development strategies, 505(b)(2) pathway requires careful consideration and planning taking into account all the potential issues. This pathway is particularly attractive to manufacturers transitioning from generic drugs to innovator products. However, there are unique challenges to developing such products – scientific, regulatory, logistical and financial – all of which could convert a potentially attractive project into a constant headache.                                   

                                                                                   Click Here to Register
Why should you atte​nd:
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This seminar will discuss the practical strategies for drug development via 505(b)(2) regulatory pathway. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of interactions with the FDA, global clinical trials, market access, reimbursement issues and projected trends for the near future. Lastly, the 505(b)(2) pathway will be compared to that for biosimilars.
​Learning Objectives:

At the end of the seminar, the attendees will be familiar with the following:
  • FDA guidance on 505(b)(2) products
  • Gap analysis and IND strategy for new formulations of previously FDA-approved drugs
  • Meeting with FDA to discuss 505(b)(2) submissions
  • Trends in FDA review of INDs and NDAs for 505(b)(2) products
  • Do’s and Don’ts for development plans for 505(b)(2) products​

Areas Covered in the Session:
  • The 505(B)(2) regulation and guidance from the FDA
  • Strategic considerations before embarking on a 505(b)(2) development project
  • Intellectual property issues with such products
  • Key development steps for such products
  • FDA’s review process and ongoing consultation
  • Challenges to developing 505(b)(2) product and possible solutions
  • Examples of successful strategies for developing such products
  • Searching for a 505(b)(2) project, future trends
  • 505(b)(2) and biosimilars
Who will benefit:

The following individuals or disciplines will benefit from attending this Webinar:
  • Regulatory affairs professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Drug discovery and development professionals (R&D and CMC)
  • Intellectual property experts
  • Project Managers and Clinical trial specialists
  • Regulatory Compliance Associates and Managers
  • People investing in FDA-regulated product development projects
Date: December 10, 2024
Time: 12 PM EST
​Duration: 60 Minutes

Speaker
Mukesh Kumar, PhD, RAC 
CEO, FDA Map
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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: [email protected]