🇺🇸 FDA CDER Generic Drug Forum (GDF) 2024

Events / Workshops / Webinars
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Generic Drugs Forum (GDF) 2024:
Regulatory Considerations to Enhance Generic Drug Access
April 10-11, 2024

The Generic Drugs Forum is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process

Event Page: https://sbiaevents.com/gdf2024/

Registration: https://concerted.adobeconnect.com/gdf2024/event/registration.html

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@trust_user_a @trust_level_1 @trust_user_c

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Thanks for sharing Naiffer! This sounds like a very interesting event!

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I am really looking forward to this event … ‘Risk Assessment’

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My registration is completed. Thank you Naiffer.

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I added the link to the streaming of GDF 2024 Day 2. Please check them.

Nitrosamine Risk Assessment in Type II DMFs Supporting GDUFA Applications
Dr. Govindaraj Kumaran

Slides
D2S06-Kumaran.pdf (422.8 KB)

Q&A

Q. Duplex sequencing is acceptable instead of TGR?
Q. Does the API manufacturer need to submit a risk assessment document to the agency?

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I want to add Challenge Question #1. B. Secondary amine is the answer.

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image883×538 81.3 KB

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