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In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)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

AUGUST 2, 2024

Letter Program Tag Commitment Due Date MDUFA International Harmonization Commencing with FY 2024, publish an annual assessment of the international harmonization activities described the strategic plan due by the end of FY 2023.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

MAY 3, 2024

Patrizia Cavazzoni Patrizia Cavazzoni May 6 Friends of Cancer Research; Parker Institute for Cancer Immunotherapy Unlocking Complex Cell-based Gene Therapies Peter Marks, Namandjé Bumpus, Nicole Verdun, Iwen Wu, Asha Das, Anna Kwilas, May 6-9 Association of Public Health Laboratories APHL Annual Conference Numerous May 7 Reagan-Udall Foundation for (..)

FDA 40

FDA Science Regulations Clinical Trials 40