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. Impact of a five-dimensional framework on R&D productivity at AstraZeneca.

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The Pharma Data

JANUARY 11, 2021

The first co-published, peer-reviewed research paper between a commercial MPS provider and a regulator, demonstrates that data derived using CN Bio’s proprietary PhysioMimix system is appropriate for use in drug safety and metabolism applications, evidencing its enhanced performance versus standard techniques. Source link.

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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).

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Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

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. Pivotal (i.e.,

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FDA Science Small Molecule Immune Response 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.

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Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

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Agency IQ

JANUARY 26, 2024

For devices that are implanted and therefore intended to be in contact with the patient for long periods of time, the question of how materials hold up over time and interact with a patient’s system is a high priority one for device manufacturers and regulators. starting, intermediate and final degradation).

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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.

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Research Engineering Disease Science 119

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. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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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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Animal Testing Regulations Production Marketing 40

Agency IQ

JUNE 28, 2024

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. Some of these are laboratory and animal tests, cadaveric studies and data from similar devices.

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PLOS: DNA Science

APRIL 4, 2024

The products infiltrate the many folds and crevices of a vast human skinscape. The earliest patent I found was issued in late 2009, for “Products and Methods for Reducing Malodor from the Pudendum.” Mandelic acid lowers the pH, so in ad-speak the product line is “pH-optimized.” ” For everyone.

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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 It also means that most agencies covered by the bill will be required to absorb pay cost increases.”

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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 59

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

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Therapies FDA Production Disease 59

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.

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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. It demands protocols, regulations, and collaborative efforts between human beings. Subscribe to Asimov Press.

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