Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? The global preclinical CRO market was estimated to be valued at US$5.7

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Agency IQ

NOVEMBER 27, 2023

ECHA issues research wish list to aid in its regulatory endeavors The European Chemicals Agency is attempting to guide scientific research toward topics with regulatory relevance. Second , ECHA is requesting further research addressing chemical pollution in the natural environment.

Animal Testing 40

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Agency IQ

JANUARY 19, 2024

This also has clear potential to reduce animal testing, another key commitment made by the Commission. The Omnibus Regulation has four main articles reattributing responsibilities across the four EU agencies primarily concerned with chemical regulation. Article 3 redirects tasks to ECHA regarding medical devices.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

Codon

JULY 21, 2024

Xander Balwit offers concrete proposals for raising the welfare of animals used in biomedical research for our final article in Issue 03. These rats, known as AA or P-lines, serve as animal models of alcoholism, exhibiting high alcohol-seeking behavior, withdrawal symptoms, and a predisposition to co-abuse ethanol and nicotine.

Research 123

Research Engineering Disease Science 123

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. BY PATRICIA ISCARO, ESQ. |

Animal Testing 40

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Agency IQ

JUNE 28, 2024

Requirements for clinical investigations under the MDR are outlined in MDR Articles 62 – 80 and Annex XV. See here for an in-depth analysis of those recommendations , but in short, CORE-MD presented findings from research about the impact of the MDR on certain high-risk medical devices. Data outside the PMCF (section 9.4)

Trials 40

Trials Marketing Clinical Trials Disease 40

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. see AgencyIQ’s article here for background on 1S1A.] “If

Regulations 40

Regulations International Government Compliance 40

Agency IQ

JANUARY 26, 2024

Further, the agency issued guidance in 2021 on peripheral vascular atherectomy devices that focused, in part, on concerns about coating integrity (and coating particulate testing), and has contracted research on long-term effects of other coating materials.

FDA 40

FDA Animal Testing Packaging Regulations 40

The Pharma Data

JANUARY 11, 2021

CAMBRIDGE, England–( BUSINESS WIRE )– CN Bio , a leading developer of single and multi organ-on-chip microphysiological systems (MPS) that improve the accuracy and efficiency of drug discovery, today announced the publication of co-authored research with the U.S. Food and Drug Administration (FDA) 1.

FDA 40

FDA Animal Testing Clinical Trials Pharmaceuticals 40

Agency IQ

AUGUST 18, 2023

BY RAYAN BHARGAVA, MSCAUG 16, 2023 10:33 AM CDT International: World Health Organization The International Agency for Research on Cancer (IARC) classification framework is particularly well-known , consisting of four levels of increasing certainty regarding human cancer risk. please read AgencyIQ’s August 8, 2023 article here.]

International 40

International Regulations Packaging Animal Testing 40

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 40

FDA Science Small Molecule Immune Response 40

Codon

MARCH 14, 2023

Mice and rats account for 95 percent of all animals used in biomedical research. For every 5,000 drug compounds tested in mice, five move into human studies. ” A recent article in The New Yorker suggests a solution to the problem. About 80% of drugs are tested only on male mice. .” Free-range mice?

DNA 52

DNA Laboratories Engineering Animal Testing 52

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 Featuring previous research by Walker Livingston.

FDA 40

FDA Packaging Science Drugs 40

Codon

JUNE 2, 2024

Read our full Editors’ Note and preview upcoming articles by clicking here. Read this article on our website by clicking here. It took another five years for a pair of American researchers to come up with an explanation before going on to pioneer the mouse as biomedicine’s premier model organism.

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Laboratories Research Disease Science 127

Agency IQ

JULY 12, 2024

Section 201(ff) of the FD&C Act authorizes FDA, in its discretion, to issue a rule after notice and comment, finding that the article would be lawful” under the FD&C Act. It’s also interesting to see what isn’t on this list. provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022.

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Regulations FDA Science Production 40