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. 1 The concept of in-silico models as surrogate for animal models is also an option for drug developers to generate initial safety data.

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Agency IQ

JUNE 28, 2024

This week, the MDCG issued a guidance document to help manufacturers of orphan devices navigate MDR clinical data requirements Quick background: The Commission organized an orphan device task force (ODTF) in late 2022 to tackle the unique clinical challenges for this device type.

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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. AgencyIQ has the highlights. As POLITICO reported , this generally represents a 5.2% This is already raising some red flags.

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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 provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022. It’s also interesting to see what isn’t on this list.

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