Packaging Pharma Conference Workshop 
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Comments Close Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance Draft Guidance August 5 Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for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 (..)
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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)
Agency IQ
JULY 8, 2024
Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.
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