Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

MARCH 1, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes Request for Information February 29 (Extended) Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments Draft Guidance March 11 Advanced Manufacturing Technologies Designation Program Draft Guidance March (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

OCTOBER 27, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016.

FDA 40

FDA Science Regulations Production 40