Agency IQ

MAY 3, 2024

Start Date End Date Event Event Type Center 04/29/2024 04/29/2024 Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization Series Town Hall CDRH 04/30/2024 04/30/2024 Webinar – Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act Webcast CDRH 05/01/2024 05/01/2024 (..)

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

AUGUST 2, 2024

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., use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)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