Information and interesting ideas

Topics posted here will be in the realm of bioanalysis and biomarkers as part of new therapeutic development, with the occasional post of scientific topics that I find interesting.

Wednesday, March 29, 2023

FDA Webinar: Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products

 From the announcement:

The FDA is seeking input on methods, approaches, logistics, privacy concerns, and other aspects related to efficacy and safety data collection in the post-approval setting for cell and gene therapies. 

Meeting Logistics and Registration

  • Date: Thursday, April 27, 2023
  • Time: 12:00 p.m.–4:30 p.m. ET
  • Location: This is a virtual public listening meeting and will be held via Zoom.
  • Registration: This meeting is free and open to the public; however, registration is required. Early registration is recommended. Please register for the event nowExternal Link Disclaimer.

Registration will close on Wednesday, April 26, 2023 at 11:59 p.m. ET. A recording and other relevant meeting materials will be posted online following the event. 

If you would like to speak, the registration site has the information, but you must requests to make oral presentations by 11:59 p.m. ET on March 30, 2023 ET.

Written or electronic comments are also invited and directions are at the website.

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