Animal Testing, FDA and Regulations - Drug Discovery Digest

77% of researchers not using alternatives to animal testing

Drug Discovery World

JULY 15, 2024

New survey findings have revealed that 77% of R&D professionals are not using in vitro cell-based alternatives to animal testing, and only 23% describe themselves as ‘very familiar’ with any kind of animal model alternative. This comes despite new laws, such as the FDA Modernization Act 2.0

Animal Testing

Animal Testing Research Pharma Companies Regulations

Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects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

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know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By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. For instance, FDA highlights risks associated with everyday activities (e.g.,

FDA

FDA Animal Testing Engineering Regulations

Scottish drug discovery: advancing new research models

Drug Discovery World

MAY 25, 2023

The aim of the researchers is to understand the mechanisms that regulate cancer cell proliferation, survival and dissemination; to identify critical components of these pathways as targets for novel cancer therapies; and to help translate this knowledge to patient benefit.

Research

Research Drugs Virus Disease

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

Vial

MAY 20, 2024

However, because clinical CROs are involved with studies that rely on human subjects, they must adhere to strict regulatory guidelines in each participating country of a trial, as set by bodies like the United States Food and Drug Administration (FDA).

Clinical Research

Clinical Research Research Clinical Trials Laboratories

CN Bio named winner with most impactful industry collaboration

Drug Discovery World

NOVEMBER 23, 2023

Coupled with increasing awareness around ethical considerations and the increasing cost of animal studies, there is growing interest in New Approach Methodologies (NAMs), such as OOC, to provide effective, predictive preclinical models.

Animal Testing

Animal Testing FDA Clinical Trials Government

Advanced 3D cell-based technologies

Drug Target Review

SEPTEMBER 19, 2023

The US FDA Modernisation Act 2.0., 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.

Animal Testing

Animal Testing Clinical Trials Pharmaceutical Companies FDA

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

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 Science Small Molecule Immune Response

Human neuronal cells: possibilities in drug safety testing

Drug Target Review

SEPTEMBER 26, 2023

Our approach to seizure liability screening is especially pertinent in the context of the recent FDA modernization act which allows applicants to use methods other than animal testing to establish drug safety and effectiveness. Ther Innov Regul Sci. Regul Toxicol Pharmacol RTP. 2018;53(4):519–25. Rockley KL.

Drugs

Drugs FDA Disease Animal Testing

CN Bio’s PhysioMimix Technology Receives FDA Recognition

The Pharma Data

JANUARY 11, 2021

Food and Drug Administration (FDA) 1. This co-publication with the FDA provides evidence of the advantage of MPS over standard techniques and clear criteria to ensure robust operation, both critical factors to enable the fast-track adoption of these technologies.

FDA

FDA Animal Testing Clinical Trials Pharmaceuticals

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

PLOS: DNA Science

APRIL 4, 2024

Fishy Regulations Lume falls under the cosmetic category at FDA and so needn’t have undergone clinical trials, because it doesn’t treat an illness or condition. If each ingredient is recognized as safe, then manufacturing complies with FDA regulations. Remember the statins?

Disease

Disease Testimonials Production FDA

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

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 Science 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

Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates Congressional appropriators this week released the text of the legislation that is set to provide FY2024 funding for the FDA, following a short-term continuing resolution (CR) to fund the agency and related Departments through date.

FDA

FDA Packaging Science Drugs

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

MAY 10, 2023

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. This stage is more highly regulated and consists of both preclinical testing and clinical trials. Drug discovery and development is an arduous process that can cost upwards of $2.6

Small Molecule

Small Molecule Pharmaceutical Companies Animal Testing Pharmaceuticals

Everything Wrong with Mouse Studies (Kinda)

Codon

MARCH 14, 2023

” About 6% of all mouse genes are regulated in sex-specific ways. Each animal had a different microbiome. The FDA used to require animal tests before a human drug trial could proceed; they reversed that decision in January. .” Other scientists have said much the same thing since at least 2018.

DNA

DNA Laboratories Animal Testing Engineering

Drug Discovery Digest

77% of researchers not using alternatives to animal testing

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

Trending Sources

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

Scottish drug discovery: advancing new research models

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

CN Bio named winner with most impactful industry collaboration

Advanced 3D cell-based technologies

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

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

Human neuronal cells: possibilities in drug safety testing

CN Bio’s PhysioMimix Technology Receives FDA Recognition

How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

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

Raising Welfare for Lab Rodents

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

Accelerating NDA filing through faster carcinogenicity assessment

Everything Wrong with Mouse Studies (Kinda)

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