CMC considerations for INDs and NDAs for Products

Date: April 25, 2025
Duration: 60 Minutes
Time: 12 PM EST

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 attend:
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

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

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

We accept credit card, debit card, and PayPal.

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.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

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.