Agency IQ

OCTOBER 12, 2023

In their view, this breach of procedure was that the two EFSA “statements” from 2019 were relied on in place of any document publicized as a “conclusion.” Just because a document does not include the word conclusion in its title does not mean it cannot fulfil that role in the renewal process.

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Agency IQ

JANUARY 12, 2024

The framework supports EPA’s mandate to develop and implement alternative test methods and strategies, or new approach methodologies (NAMs), that do not require vertebrate animal testing for assessing risk of injury to health or the environment. The most recent version of the document listing the categories is from 2010.

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Agency IQ

JANUARY 26, 2024

However, the agency has worked more recently on coating-specific guidance documents for other device types, including a final guidance from October 2019 on intravascular catheter systems with lubricious coatings. complete test reports do not need to be submitted to FDA).”

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Agency IQ

JUNE 7, 2024

According to a follow-up document (direct download) concerning a resolution on the EU’s authorization procedure for pesticides, the Commission noted that 21 safeners were “known to be used in plant protection products.” According to the follow-up document cited before, 13 synergists are known to be used in PPPs.

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Agency IQ

JUNE 28, 2024

While the limited pre-market clinical data still must be “sufficient,” the document offers potential alternative clinical trial designs and statistical considerations. The document is organized into 10 sections, with the first four encompassing abbreviations and terminology, introduction, scope, and orphan device status.

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FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The issues appropriate for an INTERACT meeting typically relate to IND requirements, such as questions about IND-enabling studies, complex manufacturing technologies or processes, development of innovative devices used with a drug or biologic, or the use of New Approach Methodologies (methods to be used in place of traditional animal testing).

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Agency IQ

JANUARY 19, 2024

This also has clear potential to reduce animal testing, another key commitment made by the Commission. For in-depth analysis of the CARACAL documents on the CDPC see AgencyIQ’s July 10, 2023 article. ] This proposal is long overdue, as it was initially slated for the first quarter of 2023. [

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Agency IQ

AUGUST 18, 2023

E Evidence of Non-carcinogenicity for Humans Agents that show no evidence for carcinogenicity in at least two adequate animal tests in different species or in both adequate epidemiologic and animal studies. It is puzzling why these two systems differ as much as they do despite stemming from the same parent organization.

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Agency IQ

MARCH 7, 2024

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. Streamlining these processes, according to the proposal, should improve transparency and reduce administrative efforts for stakeholders.

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Agency IQ

AUGUST 4, 2023

Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animal testing within the cosmetics and chemical sectors.

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Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics. Nonclinical studies encompass much more than just animal studies.

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Codon

JULY 21, 2024

As I continued through the museum—which documents the intentional modification of life by humans—I recalled what the writer Hugh Raffles once said about how research animals “not only bear the burdens of our dreams of health and longevity but also assume the task of living out our nightmares.”

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Agency IQ

MARCH 7, 2024

Further, the agency would need to make a separate table finding “at least $8,500,000,” for cosmetics regulation implementation ($7 million of that) and work on finding alternatives to animal testing ($1.5 To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com ).

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Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Key Documents and Dates Unified Agenda of Regulatory and Deregulatory Actions – Spring 2024

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Drug & Device Law

NOVEMBER 6, 2023

Among the types of device testing addressed by the Implant Draft Guidance are: (1) “engineering analysis,” (2) “materials specifications,” (3) “finite element analysis,” (4) “bench model testing,” and (5) “animal testing,” particularly when “knowledge and refinement of surgical technique. . .

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