Webinars >>FDA Regulations
CMC Considerations for INDs and NDAs for 505(b)(2) Products

The Chemistry, Manufacturing and Controls (CMC) section of IND and NDA applications for 505(b)(2) products raises several issues since portions of the information may come from the reference product with additions unique to the said application. Since such products may contain altered versions of previously FDA-approved drugs, sponsors frequently struggle with defining the detail and scope of information to include in their applications. This seminar would highlight the key elements of the CMC section of an IND and NDA application for a 505(b)(2) product using examples and case studies.
Why should you atte​nd:
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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.
Areas Covered in the Session:
  • 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
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: November 28, 2023
Time: 12 PM ET        
​Duration: 60 Minutes

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com