FDA Law Blog: Biosimilars

OCTOBER 10, 2023

Bench Model Testing “Testing using model systems with representative materials, geometries, and/or other simulated use parameters to evaluate the implant and demonstrate SE.” We suggest consulting the draft guidance for a few representative examples of situations in which FDA may recommend animal testing.

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Drug Target Review

SEPTEMBER 10, 2024

FDA no longer has to require animal testing for new drugs. 2023 Jan 13;379(6628):127-128 2 Tan KW, et al. 2023 Jan-Dec;15(1):2220150. References: 1 Wadman M. Rapidly accelerated development of neutralizing COVID-19 antibodies by reducing cell line and CMC development timelines. Biotechnol Bioeng. 2022 Dec 8:10.1002/bit.28302

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Vial

MAY 20, 2024

billion in 2023 and is expected to grow at a CAGR of 7.0% One of the key challenges that accompanies this early phase of drug development is ensuring the preclinical CRO’s team of scientists select effective tests to accurately evaluate a new drug candidate. between 2024 and 2030.

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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. This proposal is long overdue, as it was initially slated for the first quarter of 2023. [ For in-depth analysis of the CARACAL documents on the CDPC see AgencyIQ’s July 10, 2023 article. ]

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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. EPA proposed updates to New Chemicals Regulations under TSCA in May 2023.

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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.]

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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. 2023 Mar;139:105345. cited 2023 Jun 15]. Regul Toxicol Pharmacol RTP. Rockley KL.

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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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Agency IQ

JUNE 28, 2024

A question-and-answer document answers common questions on clinical investigation ( read AgencyIQ’s analysis of MDCG 2021-6 here ), and a Commission guidance ( 2023/C 163/06 ) outlines the content and structure of the clinical investigation report summary. Read AgencyIQ’s analysis of those exemptions here.

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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.

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Codon

JULY 21, 2024

There is an enormously high bar for morally permissible human subjects research , but when it comes to animals, the bar is much lower. 2 This is understandable given how much we value human life, but solutions to this disparity are not zero-sum: we can also do better for animals. In fact, the science of animal welfare is exploding.

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PLOS: DNA Science

APRIL 4, 2024

A highly-tauted quality of Lume is that the effect lasts 72 hours, although a class action lawsuit filed May 2023 challenges that claim, key to the advertising. ” But, tellingly, “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.”

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Agency IQ

MARCH 7, 2024

The agency received $3,530,150,000 in direct appropriations for salaries and expenses in FY 2023, and requested $3,896,028,000 billion for FY 2024 – but is receiving $3,522,150,000 from Congress for this year (note: again, this does not include user fee program funding). One issue here: FDA staff salaries.

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Agency IQ

JULY 12, 2024

For example, the FDA does not have a proposed rule listed that would change how it regulates animal testing requirements following the passage of the FDA Modernization Act 2.0 It’s also interesting to see what isn’t on this list. provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022. and the E.C.

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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. bioRxiv (2023). This essay focuses on how we might do both, specifically for the cell. Subscribe to Asimov Press.

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Drug & Device Law

NOVEMBER 6, 2023

These actions occurred on September 7, 2023, and involve three “draft guidances” bearing on the “§510(k)” substantial equivalence clearance process for medical devices. The FDA has taken recent steps that may, or may not, affect product liability litigation. We’re discussing the “may” aspect. of the human body” for at least 30 days).

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