Agency IQ

AUGUST 2, 2024

Title Type Comments Close Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance Draft Guidance August 5 Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research (..)

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

JULY 8, 2024

Date Group Event Notable FDA Speakers July 11 UMaryland / FDA Evaluating Immuno-suppressive Effects of In Utero Exposure to Drug and Biologic Products Numerous July 15-16 Alliance for Regenerative Medicine Cell & Gene Congressional Fly-In Nicole Verdun July 18 Critical Path Institute BYOD: A Guide for Successful Implementation July 23-24 MDIC (..)

FDA 40

FDA Science Regulations Production 40