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Last Post
WEBINAR: Patient Centric Specifications: Science, Risk, and Lifecycle Strategy
0
0
15 hours ago
by
Kim Huynh-Ba
FDA revised draft PSGs for generic peptides (comments due 28 Sep 2026)
0
3
2 days ago
by
Subathra Ramamoorthy
FDA draft guidance Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
0
0
2 days ago
by
Subathra Ramamoorthy
Minutes from 07/24 PQ Meeting
0
2
9 days ago
by
Trevor Williams
FDA guideline for developing cell and gene therapy products
0
0
13 days ago
by
Kim Huynh-Ba
Friday, July 24th Pharmaceutical Quality Meeting
0
2
18 days ago
by
Trevor Williams
Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period
0
4
07-07-2026
by
Masihuddin Jaigirdar
FDA revised draft: Demonstrating Substantial Evidence of Effectiveness (FDA-2019-D-4964)
0
6
07-07-2026
by
Joseph Thomas
A new team - Excipients and Supply Chain Controls
3
14
07-06-2026
by
David Schoneker
Original post by
Kim Huynh-Ba
Minutes from 06/26 PQ Meeting
0
5
07-03-2026
by
Trevor Williams
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