Animal Testing, FDA and Regulations - Drug Discovery Digest

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog: Biosimilars

NOVEMBER 20, 2024

For FDA submissions, this strategy can be used to evaluate the biocompatibility endpoints acute, subacute, subchronic, and chronic systemic toxicity, genotoxicity, carcinogenicity, and reproductive/developmental toxicity. Many sponsors want to reduce animal testing and, therefore, welcome the approach. By Adrienne R.

Animal Testing

Animal Testing FDA Analytical Chemistry International

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device coating guidance since 1990s The FDA’s Center for Devices and Radiological Health (CDRH) has issued a new draft guidance specifically laying out the types of information it would want to see in pre-market submission for orthopedic devices with specific coating types.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

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

Webinars

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects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

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

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

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

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

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

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 Clinical Trials Research Trials

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

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 Production Testimonials 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

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

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 Engineering Animal Testing

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. Today, a single injection of an FDA-approved gene therapy, called Hemgenix , cures this disease. Subscribe to Asimov Press.

DNA

DNA RNA Molecular Biology Laboratories

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

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

Advanced 3D cell-based technologies

Webinars

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

CN Bio’s PhysioMimix Technology Receives FDA Recognition

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

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

The essential role of recombinant phage display antibody libraries

Human neuronal cells: possibilities in drug safety testing

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

Raising Welfare for Lab Rodents

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

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

Everything Wrong with Mouse Studies (Kinda)

Levers for Biological Progress

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