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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program.

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FDA Science Clinical Trials Regulations 40

Agency IQ

JUNE 2, 2023

BY ALEXANDER GAFFNEY, MS, RAC AUG 31, 2022 6:50 PM CDTUPDATED MAY 25, 2023 6:12 PM CDT What we expect to be talking about in June: Supply chain information: Under the FDORA legislation, holders of Biologics License Applications are required to submit a one-time report to the FDA on June 25, 2023 regarding which of their biologic products are available (..)

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Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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FDA Science Clinical Trials Regulations 40

Agency IQ

SEPTEMBER 29, 2023

Start Date End Date Event Event Type Center 09/27/2023 09/28/2023 13th Annual Global Summit on Regulatory Science Summit National Center for Toxicological Research 09/27/2023 09/27/2023 Cellular, Tissue, and Gene Therapies Advisory Committee Advisory Committee Meeting CBER 09/28/2023 09/28/2023 Electronic Drug Registration and Listing (eDRLS) Using (..)

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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 (..)

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FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig. Prohaska, Kavita C. The following PDUFA dates were obtained from publicly available sources.

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FDA Science Regulations Production 40