How to Increase the Odds for Success of Your 505(b)(2) Product
Date: June 12, 2025
Duration: 60 Minutes
Time: 12 PM EST
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.
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.
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
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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
