Animal Testing, Information and Regulations

Advanced 3D cell-based technologies

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0., However, building that scalable process with minimal batch variability is a challenge.

Animal Testing

Animal Testing Clinical Trials Pharmaceutical Companies FDA

Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects

FDA Law Blog: Biosimilars

MARCH 19, 2024

using phantoms, ex vivo animal tissue models, and/or in vivo animal testing), computationally, and/or clinically. When in vivo animal testing is needed, tests should follow good laboratory practices and the animal model should be representative of the intended clinical application. By Adrienne R.

Animal Testing

Animal Testing Laboratories Marketing Regulations

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

Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

Regulations

Regulations Animal Testing Production Marketing

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

Agency IQ

OCTOBER 12, 2023

While this development, on its own, is noteworthy, the judiciary rationale behind the ruling will impact wider EU trends and serve as precedent for future chemical regulation. This regulation has since been repealed and replaced with Implementing Regulation (EU) 2020/1740 , though many of the provisions and their articles remain the same.

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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know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By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

FDA

FDA Animal Testing Engineering Regulations

CN Bio’s PhysioMimix Technology Receives FDA Recognition

The Pharma Data

JANUARY 11, 2021

The first co-published, peer-reviewed research paper between a commercial MPS provider and a regulator, demonstrates that data derived using CN Bio’s proprietary PhysioMimix system is appropriate for use in drug safety and metabolism applications, evidencing its enhanced performance versus standard techniques. Source link.

FDA

FDA Animal Testing Clinical Trials Pharmaceuticals

The essential role of recombinant phage display antibody libraries

Drug Target Review

OCTOBER 3, 2024

Recently, the FDA announced that new medicines need not be tested in animals to receive regulatory approval. 3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. 2024 Jan 5;16(1).

Molecular Biology

Molecular Biology Pharmacokinetics Laboratories Animal Testing

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

Agency IQ

JANUARY 26, 2024

FDA proposes first update to orthopedic device coating guidance since 1990s The FDA’s Center for Devices and Radiological Health (CDRH) has issued a new draft guidance specifically laying out the types of information it would want to see in pre-market submission for orthopedic devices with specific coating types.

FDA

FDA Animal Testing Packaging Regulations

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

MAY 20, 2024

One of the key challenges that accompanies this early phase of drug development is ensuring the preclinical CRO’s team of scientists select effective tests to accurately evaluate a new drug candidate. Clinical trials must also be managed in such a way that the integrity of the resultant data is maintained with the highest quality.

Clinical Research

Clinical Research Clinical Trials Research Trials

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

Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

International

International Regulations Packaging Animal Testing

Raising Welfare for Lab Rodents

Codon

JULY 21, 2024

It may seem that if researchers are sufficiently concerned about the welfare of lab animals, the best thing to do would be to stop using animals altogether. However, a multitude of factors—from institutional inertia to a global animal-testing industry worth billions of dollars —make this outcome unlikely.

Research

Research Engineering Disease Science

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 plan includes a list of alternative test methods and strategies, or NAMs.

Animal Testing

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

Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

FDA

FDA Science Small Molecule Immune Response

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

Agency IQ

NOVEMBER 27, 2023

Its latest report serves as a powerful indicator for what EU chemical regulation is likely to resemble in the coming years should the agency receive sufficient scientific support to meet four regulatory challenges ECHA just can’t solve without further progress from the scientific community.

Animal Testing

Animal Testing Research Regulations Compliance

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 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

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

Agency IQ

JUNE 28, 2024

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. Annex XV describes the requirements for clinical investigations and the information needed for the clinical application.

Trials

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

Agency IQ

MARCH 7, 2024

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.

Regulations

Regulations International Government Compliance

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

Agency IQ

JANUARY 19, 2024

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.

Packaging

Packaging Regulations Laboratories Animal Testing

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog: Biosimilars

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

Animal Testing

Animal Testing FDA Analytical Chemistry International

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents. CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc.

Therapies

Therapies FDA Production Disease

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 The budget agreement “asks” the FDA for some information and activities, and “recognizes” some FDA authority in other areas.

FDA

FDA Packaging Science Drugs

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. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

Regulations

Regulations FDA Science Production

Levers for Biological Progress

Codon

NOVEMBER 1, 2024

Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animal testing — I hope others will take on these challenges in similar essays. Experiments performed at one scale don’t always produce data that are informative for experiments at other scales.

DNA

DNA RNA Molecular Biology Laboratories

Drug Discovery Digest

Advanced 3D cell-based technologies

Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects

Trending Sources

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

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

CN Bio’s PhysioMimix Technology Receives FDA Recognition

The essential role of recombinant phage display antibody libraries

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

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

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

Raising Welfare for Lab Rodents

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

Analysis Life Sciences Thank You 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

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

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

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

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

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

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

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

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

Levers for Biological Progress

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