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. 2018 Mar;17(3):167–81. 2018 Dec 11;94(10):390–411. 2018;(136):56573. 2016;81:37–46.

Drugs 111

Drugs FDA Disease Animal Testing 111

Drug Target Review

OCTOBER 3, 2024

FDA no longer needs to require animal tests before human drug trials [Internet]. 2018 Dec 5;11(1):178–90. 1975 Aug;256(5517):495–7. Crescioli S, Kaplon H, Chenoweth A, et al. Antibodies to watch in 2024. 2024 Jan 5;16(1). www.science.org. Available from: [link] ‌Baker M. Reproducibility crisis: Blame it on the antibodies.

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. BY PATRICIA ISCARO, ESQ. |

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. 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. The estrous cycle of female mice shows only “a very weak effect on their behavior.”

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

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.

Regulations 40

Regulations FDA Science Production 40

Drug & Device Law

NOVEMBER 6, 2023

is important for the device to be used safely.” For certain implants, information regarding raw materials and critical aspects of manufacturing and processing steps. . . may be important to understanding the safety. . . of the final, finished device.”

FDA 59

FDA Animal Testing Licensing Licensing 59