Remove 2026 Remove Drugs Remove Licensing Remove Packaging
article thumbnail

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

Happy 40 th Birthday, generic drugs: September 24 will mark the 40 th anniversary of the 1984 signing of the Hatch-Waxman Act, which created a formal pathway for the approval of generic drugs. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election.

FDA 40
article thumbnail

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.