FDA Roundup September 2024

The Dallas Cowboys pulled out a nail-biter last night. College football is heating up with Texas sitting at the number 1 spot in the latest rankings. We are also 38 days away from the election. Happy Friday everyone and welcome to the Seventh Edition of the FDA Roundup. At the end of each month, I will post 5 things from the FDA that I thought were the most interesting. The goal of the FDA Roundup will be for it to be a quick read and give you an overview of some of the FDA initiatives in D.C. It is not meant to be as comprehensive as the AI Healthcare Report.

1.Webinar – FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs)

Date:

October 24, 2024

Time:

1:00 PM - 2:00 PM ET

Summary

The FDA’s TPLC approach allows the FDA to review and monitor medical devices throughout their life cycle by considering all available information on safety and effectiveness.?

Please find how to attend the webinar in the link above.

2.Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices

The FDA has announced an upcoming public meeting for the Digital Health Advisory Committee. The committee aims to provide the FDA with suggestions and recommendations on regulatory issues. The meeting will discuss total product lifecycle considerations for Generative A.I.- Medical Devices.

The meeting will be held on November 20-21st from 9:00 a.m.-6:00 p.m.

3. ICH M12 Drug-Drug Interaction Studies Final Guidance

Date:

October 9, 2024

Time:

1:00 PM - 3:00 PM ET

Summary

The final guidance examines pharmacokinetic drug interactions with metabolic enzymes and drug transporters. The guidance also provides context to the analysis of the interaction of a drug during development and regulatory review.

Please find how to attend the webinar in the link above with a list of speakers included.

4. FDA Approved Drugs

Above are the latest drugs that have gone under the FDA approval process. It is crucial to note that this list does NOT include BLAs/NDAs and those applications and parts of applications approved by CBER. This resource will be a staple in the FDA Roundup. You can also see what has been approved by sorting the data!

5. Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation

Date:

November 7, 2024

Time:

1:00 PM - 2:30 PM ET

Summary

The goal of the webinar is to inform attendees of the FDA's risk evaluation and mitigation strategies (REMS) Logic Model via an earlier FDA notice.

A question and answer session will be conducted at the end of the webinar.

Please find how to attend the webinar in the link above with a list of speakers included.