Archive - September 2024
Days Go By* – Particularly When Responding to an FDA Inspection
The Greatest Trick the Devil Ever Pulled was Convincing the World He Didn’t Exist: Senate Judiciary Set to Mark-Up Patent Reform Bills that Could Significantly Affect Hatch-Waxman and the BPCIA
FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies
OPDP Says TV Ad is Out of Bounds with Fourth Untitled Letter of 2024
The National Products Association Challenges FDA’s Interpretation of the Dietary Supplement Exclusionary Clause
FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule
Happy 40th Anniversary Hatch-Waxman! We’re Celebrating By Providing Access to a New Archive
CDER Wants YOU to Tell It How to Improve the Integrated Review; We Have a Few Ideas of Our Own