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The FDA’s new roadmap In April 2025, the FDA announced a major regulatory shift with its plan to phase out the requirement for animaltesting in the development of monoclonal antibodies and other drugs, when scientifically appropriate. NIH Office of Laboratory Animal Welfare – Training Guidelines. Bailey J, et al.
As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.
Commission redoubles commitment to reduce animaltesting 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 animaltesting within the cosmetics and chemical sectors.
Commission unveils details on plan for phasing out animaltesting for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animaltesting used for chemical safety assessment.
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. What are nonclinical studies and when are they conducted in drug development?
This document can be understood as something of a dialogue between regulators and the research entities which provide them with leverageable data, as well as the methodological tools to interpret this same data’s regulatory significance. The next key area concerns the ongoing shift away from animaltesting.
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
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.
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 animaltesting for assessing risk of injury to health or the environment. The most recent version of the document listing the categories is from 2010.
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).”
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.
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.
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 animaltesting).
This also has clear potential to reduce animaltesting, 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. [
E Evidence of Non-carcinogenicity for Humans Agents that show no evidence for carcinogenicity in at least two adequate animaltests 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.
At the same time, Hojsik pointed to the positive impact that the 1S1A ambition should have on data sharing, thereby reducing animaltesting, another objective of the Green Deal. Streamlining these processes, according to the proposal, should improve transparency and reduce administrative efforts for stakeholders.
Commission redoubles commitment to reduce animaltesting 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 animaltesting within the cosmetics and chemical sectors.
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.
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.”
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 animaltesting ($1.5 To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com ).
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
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) “animaltesting,” particularly when “knowledge and refinement of surgical technique. . .
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