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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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Because this guidance covers such a breadth of information, for Part 1 of our coverage, we will focus on the non-CMC topics and summarize our top takeaways from each section, something of a Cliffs Notes for the Cliffs Notes. The draft guidance recommends that no more than 15 questions are included in the briefing package.

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Therapies FDA Production Disease 59

Agency IQ

JANUARY 26, 2024

FDA proposes first update to orthopedic device coating guidance since 1990s The FDA’s Center for Devices and Radiological Health (CDRH) has issued a new draft guidance specifically laying out the types of information it would want to see in pre-market submission for orthopedic devices with specific coating types.

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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. References: 1 Wadman M.

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Drug Development Clinical Supply Production Protein Expression 64

Agency IQ

JUNE 7, 2024

Requests need to be sent to the Commission at sante-secteur-ppp@ec.europa.eu , containing the information listed in Annex II of this regulation. Likewise, applications for approval of a safener or a synergist may be accompanied with a request “to treat certain information, including certain parts of the dossier, as confidential.”

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Regulations Animal Testing Production Marketing 40

Agency IQ

AUGUST 18, 2023

This framework is anchored in the Classification, Labeling, and Packaging Regulation (CLP) (1272/2008/EC), the bloc’s definitive legislation on classifying substances and mixtures. European Union The E.U. Currently, the CLP is aligned with parts from the sixth and seventh revised editions of the GHS.

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International Regulations Packaging Animal Testing 40

Agency IQ

MARCH 7, 2024

We don’t have the ability to go around Europe and go into every company, so we need to ensure our member states are fully informed and understand. At the same time, Hojsik pointed to the positive impact that the 1S1A ambition should have on data sharing, thereby reducing animal testing, another objective of the Green Deal.

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