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. 2018 Mar;17(3):167–81. 2018 Dec 11;94(10):390–411. 2016;81:37–46.

Drugs 111

Drugs FDA Disease Animal Testing 111

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. 2018 Dec 5;11(1):178–90.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 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

Codon

MARCH 14, 2023

” Other scientists have said much the same thing since at least 2018. ” About 6% of all mouse genes are regulated in sex-specific ways. Each animal had a different microbiome. The FDA used to require animal tests before a human drug trial could proceed; they reversed that decision in January.

DNA 52

DNA Laboratories Engineering Animal Testing 52

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.

Animal Testing 59

Animal Testing FDA Analytical Chemistry International 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.

Regulations 40

Regulations FDA Science Production 40