Agency IQ

MAY 3, 2024

Beyond litigation, expect that CDRH Director JEFF SHUREN could be called before House legislators who have already expressed displeasure at the rule.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Drug Discovery World

NOVEMBER 9, 2023

The luncheon presentation will be given by Hans Gerstmans, Postdoctoral Researcher, Laboratory for Biomolecular Discovery & Engineering, KU Leuven, VIB, alongside Wai Long Tam, Head of Technology Watch at VIB, Technology Watch, VIB.

Engineering 130

Engineering Protein Production Therapies Science 130

Agency IQ

SEPTEMBER 29, 2023

July 2023 (Under OIRA Review) Medical Devices; Laboratory Developed Tests (Proposed Rule) This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars 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

Comments on LDT Proposed Rule: On December 4, the comment period on the FDA’s Laboratory Developed Test proposed rule will close, and we will get a fuller picture of the extent to which the life sciences industry opposes the FDA’s proposal. Whatever the agency decides could result in new lawsuits or negative political attention.

FDA 40

FDA Science Regulations Production 40