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Digital Twins in Biopharm - webinar is posted in AAPS Science 360
   
1 10 14 days ago by Allison Radwick
Original post by Bhasker Sambar
FDA releases a guidance revision draft entitled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products"
   
0 1 16 days ago by Mark Arnold
Reminder for the upcoming Webinar - Digital Twins (Regulatory Science Community meeting)
   
0 3 20 days ago by Bhasker Sambar
FDA posted a revised draft guidance "Master Protocols for Drug and Biological Product Development".
   
1 2 21 days ago by Robert Falcone
Original post by Mark Arnold
June 26 from noon to 1pm A digital twins conversation with Dough Kiehl and monthly Regulatory Science meetings
   
1 10 22 days ago by Bhasker Sambar
Original post by Allison Radwick
FDA final guidance "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug"
   
0 5 27 days ago by Mark Arnold
FDA FY 2026 Generic Drug Science & Research Workshop - Topics for Submission
   
0 2 30 days ago by Bhasker Sambar
USP Opens Four Draft Biologics Method Standards for Early Comment
   
0 1 06-12-2026 by Allison Radwick
Upcoming Meeting Dates with Teams link
   
0 1 06-09-2026 by Trevor Williams
Do you follow regulatory guidance outside the US? Help build our global regulations, harmonization and submission focus area
   
1 2 06-04-2026 by Robert Falcone
Original post by Allison Radwick
Showing 1 to 10 of 20 threads (20 total posts)