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 52

FDA Animal Testing Science Production 52

Reprocell

MARCH 6, 2023

A recent law passed in the USA means that new drugs do not need to be tested on animals before human studies. With support from over 200 organizations, the "FDA Modernization Act 2.0" expands the range of models that can be used to test a compound before clinical trials.

FDA 52

FDA Animal Testing Clinical Trials Trials 52

Crown Bioscience

APRIL 12, 2023

The development of new drugs and biological products has traditionally mandated animal testing, but the FDA Modernization Act 2.0 allows for alternative non-clinical testing, allowing reliable alternatives for drug discovery and biological product applications.

Animal Testing 52

Animal Testing Drugs FDA Production 52

Drug Discovery World

MAY 9, 2023

The recent passage of the FDA Modernization Act, which removed the requirement for animal testing when suitable alternatives are available, has highlighted the inadequacy of animal models most often used for in vivo research. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

Drug Development 130

Drug Development Clinical Trials Animal Testing Cell Based Assays 130

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88

Animal Testing 105

Animal Testing Drugs Clinical Trials Clinical Research 105

Drug Discovery World

FEBRUARY 2, 2023

As of late December 2022, the US Food and Drug Administration (FDA) no longer needs drugs to be tested in animals to receive approval, according to legislation signed by President Joe Biden 1 – the Modernization Act 2.0. Ultimately, the FDA Modernization Act 2.0

Animal Testing 130

Animal Testing FDA Clinical Trials Cell Based Assays 130

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 59

Animal Testing Laboratories Marketing Regulations 59

Drug Discovery World

MARCH 20, 2024

In response to these challenges, the newly passed FDA Modernization Act 2.0 has made a landmark shift by recognising the limitations of animal models and empowering researchers to adopt non-animal methods to demonstrate drug safety and efficacy. Backed by the FDA Modernization Act 2.0,

Animal Testing 148

Animal Testing Research Clinical Trials Drug Development 148

Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development. This was confirmed in human trials and the drug was subsequently approved by the FDA.

Animal Testing 148

Animal Testing Disease Trials Research 148

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 45

FDA Animal Testing Engineering Regulations 45

Drug Discovery World

MAY 25, 2023

Rodgers said that the FDA Modernisation Act had encouraged a reduction in animal testing and opened up new opportunities, allowing human disease models technology to advance at a faster rate.

Research 130

Research Virus Drugs Disease 130

Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Because of this, oncology researchers may only have access to minimal existing scientific literature related to cell-based data and animal testing to predict an investigational therapy’s effect on human factors.

Trials 52

Trials Clinical Trials FDA Approval Animal Testing 52

biobide

JANUARY 5, 2024

The Food and Drug Administration (FDA) Modernization Act 2.0 At its core lies a pivotal stride toward more humane and scientifically advanced practices through the authorization for the use of certain alternatives to animal testing in Drug safety and efficacy investigations.

Animal Testing 59

Animal Testing FDA Pharmaceuticals Production 59

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 52

Clinical Research Research Clinical Trials Laboratories 52

Drug Discovery World

APRIL 12, 2023

By DDW Editor Reece Armstrong A lot has already been said about the US Food and Drug Administration’s (FDA) Modernization Act 2.0 The decision by the Biden administration to end the federal requirement for drugs under development to be tested on animals represents a significant step forward for the life sciences sectors.

FDA 130

FDA Animal Testing Cell Based Assays Clinical Trials 130

The Pharma Data

MAY 15, 2021

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! FDA registered and GMP (good manufacturing practices) certified facility. Ceracare is a natural supplement containing powerful antioxidants that help support detoxify your body and support blood sugar.

Production 52

Production Animal Testing Doctors Testimonials 52

The Pharma Data

MAY 14, 2021

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! FDA registered and GMP (good manufacturing practices) certified facility. Unity is a natural supplement containing powerful antioxidants that help support detoxify your body and support weight loss.

Production 52

Production Animal Testing Doctors Testimonials 52

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 148

Animal Testing FDA Clinical Trials Government 148

Drug Discovery World

OCTOBER 20, 2023

The latest sponsored DDW Sitting Down With podcast features Professor Jonathan Blackburn, Chief Scientific Officer of Sengenics, who discusses the advantages of functional protein microarrays, challenges to overcome for biomarker discovery, Sengenics ’ new i-Ome Discovery chip, and more.

Production 130

Production Animal Testing Drugs FDA 130

Drug Discovery World

OCTOBER 19, 2023

The latest sponsored DDW Sitting Down With podcast features Professor Jonathan Blackburn, Chief Scientific Officer of Sengenics, who discusses the advantages of functional protein microarrays, challenges to overcome for biomarker discovery, Sengenics ’ new i-Ome Discovery chip, and more.

Production 130

Production Animal Testing Drugs FDA 130

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu. And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA. Tobolowsky — Much has changed since the long-gone days of 2017.

FDA 64

FDA Packaging Animal Testing Production 64

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 40

FDA Animal Testing Packaging Regulations 40

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 40

FDA Science Small Molecule Immune Response 40

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 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

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 40

FDA Animal Testing Clinical Trials Pharmaceuticals 40

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. Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, et al. Ther Innov Regul Sci. Rockley KL.

Drugs 111

Drugs FDA Disease Animal Testing 111

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. That’s why FDA requires post-marketing follow-up data.

Disease 65

Disease Testimonials Production FDA 65

Drug Discovery World

FEBRUARY 27, 2023

The launch follows the FDA Modernisation Act 2.0 which removes the mandatory requirement for animal testing in the development of drugs for toxicity where enhanced performance is proven using in vitro alternatives.

Laboratories 130

Laboratories Animal Testing Production Compliance 130

The Premier Consulting Blog

APRIL 25, 2023

President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. As a result, the FDA is now required to consider alternatives to animal testing, such as in vitro , in silico , and in chemico tests and models.

FDA 52

FDA Animal Testing Pharmacokinetics Small Molecule 52

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 40

FDA Packaging Science Drugs 40

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 121

Research Engineering Science Laboratories 121

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 40

Regulations FDA Science Production 40

Drug Discovery World

MAY 10, 2023

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. However, in the late 1990s, regulatory agencies including the FDA began to accept the use of shorter medium-term bioassays in transgenic mice as a substitute for one of the two required lifetime studies.

Small Molecule 130

Small Molecule Pharmaceutical Companies Animal Testing Pharmaceuticals 130

Codon

MARCH 14, 2023

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. .” When they repeated the experiment on identical mice, of the same strain and from the same vendor, those mice gained bone density.

DNA 52

DNA Laboratories Engineering Animal Testing 52

The Pharma Data

OCTOBER 27, 2020

The experimental drugs are concentrated versions of one or two specific antibodies that worked best against the coronavirus in lab and animal tests, the AP reported. Remdesivir gets full FDA approval to treat COVID-19. National Institutes of Health, the FDA announced in a statement. Food and Drug Administration.

Trials 52

Trials Hospitals Drugs FDA 52

Codon

JUNE 2, 2024

” It’s an uncharitable take, but when drugs fail as often as they do despite animal testing, it’s not hard to see the JAX mice as a metaphor for a biomedical enterprise cloistered away from the real world. The FDA itself believes these types of early human studies are underutilized.

Laboratories 123

Laboratories Research Disease Science 123

Drug & Device Law

NOVEMBER 6, 2023

The FDA has taken recent steps that may, or may not, affect product liability litigation. Our interest in the FDA’s draft guidances is whether they undercut Lohr ’s statement about the §510(k) process – by demonstrating that, in administering it, the FDA actually is concerned about the safety of “substantially equivalent” devices.

FDA 59

FDA Animal Testing Licensing Licensing 59