FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.”

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? There will probably already be some clinical data for the drug in question and this can save both time and money, as the company can secure regulatory approval without lengthy and costly early-stage clinical trials.

Clinical Pharmacology 100

Clinical Pharmacology Clinical Trials Drugs Trials 100

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. 2009 Sep;14(17–18):876–84. Neurotoxicology. 2010 Aug;31(4):331–50. Drug Discov Today.

Drugs 111

Drugs FDA Disease Animal Testing 111

PLOS: DNA Science

APRIL 4, 2024

The earliest patent I found was issued in late 2009, for “Products and Methods for Reducing Malodor from the Pudendum.” 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. ” Lady parts.

Disease 76

Disease Testimonials Production FDA 76

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.

Research 113

Research Engineering Science Disease 113

Codon

MARCH 14, 2023

In 2009, a small group of Dutch biologists rounded up some lab mice, stabbed them with needles, and harvested their blood. None of them were beneficial, and “eight of these compounds ultimately failed in clinical trials, which together involved thousands of people.” Each animal had a different microbiome.

DNA 52

DNA Laboratories Animal Testing Engineering 52