Agency IQ

SEPTEMBER 29, 2023

This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies.

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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S.

FDA 40

FDA Science Regulations Production 40