Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. This also has clear potential to reduce animal testing, another key commitment made by the Commission.

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Drug Target Review

SEPTEMBER 10, 2024

However, developing an accelerated IND application requires that good laboratory practice (GLP) toxicological data must be generated, collected, interpreted and integrated in the IND-enabling data package. FDA no longer has to require animal testing for new drugs. 2023 Jan 13;379(6628):127-128 2 Tan KW, et al.

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Agency IQ

AUGUST 18, 2023

BY RAYAN BHARGAVA, MSCAUG 16, 2023 10:33 AM CDT International: World Health Organization The International Agency for Research on Cancer (IARC) classification framework is particularly well-known , consisting of four levels of increasing certainty regarding human cancer risk. please read AgencyIQ’s August 8, 2023 article here.]

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Agency IQ

JUNE 28, 2024

A question-and-answer document answers common questions on clinical investigation ( read AgencyIQ’s analysis of MDCG 2021-6 here ), and a Commission guidance ( 2023/C 163/06 ) outlines the content and structure of the clinical investigation report summary. Read AgencyIQ’s analysis of those exemptions here.

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Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. Further, the funding specifically for Buildings and Facilities was also reduced by a little under $8 million from FY 2023 levels.

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Agency IQ

JULY 12, 2024

For example, the FDA does not have a proposed rule listed that would change how it regulates animal testing requirements following the passage of the FDA Modernization Act 2.0 It’s also interesting to see what isn’t on this list. provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022. and the E.C.

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Codon

NOVEMBER 1, 2024

Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animal testing — I hope others will take on these challenges in similar essays. bioRxiv (2023). This essay focuses on how we might do both, specifically for the cell. Subscribe to Asimov Press.

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