Animal Testing and Document - Drug Discovery Digest

Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

Animal Testing

Animal Testing Regulations Production Research

Analysis Chemical: Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

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.

Animal Testing

Animal Testing Research

Analysis Chemical Thank You Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

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.

Animal Testing

Animal Testing Regulations Production Research

Analysis Life Sciences: FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

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. What are nonclinical studies and when are they conducted in drug development?

FDA

FDA Animal Testing Science Drug Development

Analysis Chemical Thank You ECHA issues research wish list to aid in its regulatory endeavors

Agency IQ

NOVEMBER 27, 2023

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 animal testing.

Animal Testing

Animal Testing Research Regulations Compliance

Analysis Chemical Thank You EU court upholds ban on chlorpyrifos-methyl, setting regulatory precedent in the process

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.

Regulations

Regulations Animal Testing Government Production

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

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.”

FDA

FDA Animal Testing Engineering Regulations

Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

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

FDA Animal Testing Packaging Regulations

Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

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

Animal Testing Regulations Production Marketing

Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

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

Regulations Animal Testing Production Marketing

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

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.

Trials

Trials Marketing Clinical Trials Regulations

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

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.

FDA

FDA Small Molecule Science Immune Response

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

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. [

Packaging

Packaging Regulations Laboratories Animal Testing

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

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).

FDA

FDA Packaging Animal Testing Production

Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

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.

International

International Regulations Packaging Animal Testing

Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

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.

Regulations

Regulations International Government Compliance

Raising Welfare for Lab Rodents

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.”

Research

Research Engineering Disease Science

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

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

Regulations FDA Science Production

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

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 ).

FDA

FDA Packaging Science Drugs

Tort-Related Implications of Recent FDA Device Draft Guidances

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. . .

FDA

FDA Animal Testing Licensing Licensing

Drug Discovery Digest

Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

Analysis Chemical: Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

Trending Sources

Analysis Chemical Thank You Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

Analysis Life Sciences: FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Analysis Chemical Thank You ECHA issues research wish list to aid in its regulatory endeavors

Analysis Chemical Thank You EU court upholds ban on chlorpyrifos-methyl, setting regulatory precedent in the process

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

Raising Welfare for Lab Rodents

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Tort-Related Implications of Recent FDA Device Draft Guidances

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