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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Packaging Regulations Laboratories Animal Testing 40

Agency IQ

JUNE 7, 2024

Safeners and synergists are subject to the same approval conditions that active substances are under the PPPR’s Articles 4 and 5-21 , pursuant to Article 25(1)-(2). Under the PPPR, first-time approvals are expected to take between 2.5 PPPs using approved active substances must obtain separate authorizations at the national level.

Regulations 40

Regulations Animal Testing Production Marketing 40

Agency IQ

JANUARY 26, 2024

Shelf life and packaging: The guidance offers information on what FDA reviewers would need to see related to shelf life testing in two areas: sterility and device/coating function. Clinical performance testing: Generally, clinical studies are not necessary for metallic and calcium phosphate coated devices.

FDA 40

FDA Animal Testing Packaging Regulations 40

Agency IQ

MARCH 7, 2024

The “Collaboration” session, the subject of this article, encompassed three smaller segments – two shorter one-on-one interviews, and a one-hour panel discussion with representatives from EU government, trade associations, and the non-profit sector. see AgencyIQ’s article here for background on 1S1A.] “If

Regulations 40

Regulations International Government Compliance 40

Agency IQ

JUNE 28, 2024

Requirements for clinical investigations under the MDR are outlined in MDR Articles 62 – 80 and Annex XV. Other work packages for the ODTF include information about clinical evidence for this device type, conditional certification, and the use of registries to support conformity assessment. Data outside the PMCF (section 9.4)

Trials 40

Trials Marketing Clinical Trials Regulations 40

Agency IQ

AUGUST 18, 2023

please read AgencyIQ’s August 8, 2023 article here.] 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. For more on the regulation of glyphosate in the E.U., European Union The E.U.

International 40

International Regulations Packaging Animal Testing 40

Codon

MARCH 14, 2023

The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies. ” A recent article in The New Yorker suggests a solution to the problem. Free-range mice?

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DNA Laboratories Engineering Animal Testing 52