Agency IQ

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g.,

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

Trial Designs for Treatment Regimens with Multiple Phases Workshop Office of the Commissioner 05/09/2024 05/09/2024 Blood Products Advisory Committee May 9, 2024 Meeting Announcement Advisory Committee Meeting CBER 05/09/2024 05/09/2024 Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval Virtual CDER 05/09/2024 (..)

FDA 40

FDA Science Regulations Clinical Trials 40