biobide

SEPTEMBER 29, 2023

Where possible, NAM s seek to avoid the use of animal testing or at least to reduce it. However, reports drawn up as recently as June 2023 still emphasize the necessity of animal testing at some point as we are still far from understanding and reproducing all the variables present in a whole organism in an in vitro or in silico model.

Animal Testing 106

Animal Testing Drugs Pharmacokinetics Regulations 106

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0., Nature Cancer. 2022;3(4):418-36. Frontiers in Physiology.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time.

Trials 40

Trials Marketing Clinical Trials Regulations 40

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

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.

FDA 40

FDA Animal Testing Clinical Trials Pharmaceuticals 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