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.

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Animal Testing FDA Analytical Chemistry International 57

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. Fill out the form to read the full article.

Animal Testing 59

Animal Testing 59

biobide

AUGUST 18, 2023

With an increased focus on animal welfare , the beauty industry has undergone a shift towards the 3Rs Principle application and all surrounding regulations. In 2004 the European Union (EU) introduced a ban on animal testing on finished products.

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Regulations Animal Testing Production Treatment 92

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.

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Packaging Regulations Laboratories 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. Fill out the form to read the full article.

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FDA Animal Testing Science Drug Development 52

Reprocell

MARCH 6, 2023

expands the range of models that can be used to test a compound before clinical trials. 1 Under this new law animal testing can still be used, but alternative testing methods now also represent a legitimate option. With support from over 200 organizations, the "FDA Modernization Act 2.0"

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FDA Animal Testing Clinical Trials Trials 52

Agency IQ

JUNE 28, 2024

Requirements for clinical investigations under the MDR are outlined in MDR Articles 62 – 80 and Annex XV. Some of these are laboratory and animal tests, cadaveric studies and data from similar devices. Other data come from the post-market surveillance system (PMS), described in MDR Articles 83 – 91.

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Trials Marketing Clinical Trials Regulations 40

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. |

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Animal Testing Regulations Production Marketing 40

Agency IQ

MARCH 7, 2024

The “Collaboration” session, the subject of this article, encompassed three smaller segments – two shorter one-on-one interviews, and a one-hour panel discussion with representatives from EU government, trade associations, and the non-profit sector. see AgencyIQ’s article here for background on 1S1A.] “If

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Regulations International Government Compliance 40

Agency IQ

JANUARY 26, 2024

Finally, the agency recommends bench testing for evaluating the effect of the coating process on the device’s performance, including comparative physical and chemical testing of the coated substrate and comparative fatigue testing of the coated substrate.

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FDA Animal Testing Packaging Regulations 40

Agency IQ

NOVEMBER 27, 2023

The next key area concerns the ongoing shift away from animal testing. For example, under the REACH (1907/2006/EC) and CLP (1272/2008/EC) regulations, NAMs are generally only used to replace animal testing for hazard identification and classification of skin sensitizers.

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Animal Testing Research Regulations Compliance 40

Agency IQ

OCTOBER 12, 2023

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. In particular, article 13 describes the role of an EFSA conclusion in the renewal process.

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Regulations Animal Testing Government Production 40

Vial

MAY 20, 2024

In this article, we will define preclinical and clinical CROs, as well as highlight the unique needs and challenges of these organizations in their respective stages of drug research. Understanding how these two stages and types of CROs differ is fundamental to appreciating the intricate process of drug development.

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Clinical Research Clinical Trials Research Trials 52

The Pharma Data

JANUARY 11, 2021

By adopting these powerful systems, we are offering an option to help replace, reduce, refine the number of animal tests and the potential to benefit patients through the provision of safer and more efficacious therapeutics.”. ‘Impact of organ-on-a-chip technology on pharmaceutical R&D costs’ [link].

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Agency IQ

AUGUST 18, 2023

please read AgencyIQ’s August 8, 2023 article here.] E Evidence of Non-carcinogenicity for Humans Agents that show no evidence for carcinogenicity in at least two adequate animal tests in different species or in both adequate epidemiologic and animal studies. For more on the regulation of glyphosate in the E.U.,

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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.

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FDA Small Molecule Science Immune Response 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. 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.

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Research Engineering Disease Science 110

Codon

MARCH 14, 2023

The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies. ” A recent article in The New Yorker suggests a solution to the problem. Free-range mice?

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DNA Laboratories Engineering Animal Testing 52

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

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

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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. 2 An 1898 article describes the show mouse as “larger than the common household specimen. Today we launch Issue 03 of Asimov Press. 4 William Jasper Spillman , in the U.S.,

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Laboratories Research Disease Science 115