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.

Animal Testing 40

Animal Testing Regulations Production Marketing 40

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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Trials Marketing Clinical Trials Regulations 40

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.

Regulations 40

Regulations Animal Testing Production Marketing 40

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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International Regulations Packaging Animal Testing 40

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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Regulations International Government Compliance 40

Drug Discovery World

APRIL 12, 2023

Products and technologies such as cell-based assays, microphysiological systems and computer modelling will now all be regarded as suitable alternatives to animal testing in the early phases of drug development. The limitations of animal studies are widely documented.

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FDA Animal Testing Cell Based Assays Clinical Trials 130

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).”

FDA 40

FDA Animal Testing Packaging Regulations 40

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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FDA Science Small Molecule Immune Response 40

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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Packaging Regulations Laboratories Animal Testing 40

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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FDA Packaging Animal Testing Production 64

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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Research Engineering Science Laboratories 121

Drug Discovery World

MAY 10, 2023

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. When including the costs of animal housing, quantity of drug needed, and labour, at current estimates, a single study can cost in excess of $2.5 billion and take over 10 years. million USD.

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Small Molecule Pharmaceutical Companies Animal Testing Pharmaceuticals 130

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

Regulations 40

Regulations FDA Science Production 40

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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FDA Packaging Science Drugs 40

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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FDA Animal Testing Licensing Licensing 59