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).

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

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.

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

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.

Animal Testing 40

Animal Testing Regulations Production Marketing 40

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By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program.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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FDA Animal Testing Engineering Regulations 44

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. Regul Toxicol Pharmacol RTP. 2023 Mar;139:105345. Rockley KL.

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Drugs FDA Disease Animal Testing 111

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. In April 2023, the first update ( link is a direct download) from the ODTF indicated that it was working to develop a definition for orphan device.

Trials 40

Trials Marketing Clinical Trials Regulations 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 Small Molecule Science Immune Response 40

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.

Research 110

Research Engineering Disease Science 110

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. 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.

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Disease Production Testimonials FDA 98

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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Regulations FDA Science Production 40

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). These directions highlight some key topics in regulatory policy.

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FDA Packaging Science Drugs 40

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). It demands protocols, regulations, and collaborative efforts between human beings. Credit: Shaib A.H.

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DNA RNA Molecular Biology Laboratories 105