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

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in December and January FDA comment periods are typically open for 30-60 days, unless they are extended. The content will include both goals for enrollment of populations and rationales for those goals.

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FDA Science Regulations Production 40

Agency IQ

JULY 28, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. The workshop will solicit and include industry and public feedback. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40