CMC considerations for INDs and NDAs for Products
Date: April 25, 2025
Duration: 60 Minutes
Time: 12 PM EST
This seminar will discuss the practical strategies for compiling the CMC sections of 505(b)(2) applications. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of Drug Master Files (DMFs), and cross reference authorizations.
- The 505(B)(2) regulation and guidance from the FDA
- Strategic considerations for CMC section in a 505(b)(2) application
- Role of DMFs
- Best practices for using cross-reference authorization
- Common errors in CMC section in 505(b)(2) applications and potential solutions
- Examples of successful strategies for developing such products
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.
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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.
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