Remove 2023 Remove Animal Testing Remove Packaging
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Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

Agency IQ

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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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

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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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

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.

Trials 40
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Rapid delivery of toxicological material

Drug Target Review

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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Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

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.

FDA 40
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Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

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.