Reprocell

NOVEMBER 1, 2022

Pharma companies are legally required to test novel drugs in animal models before beginning human trials. And while animal testing has progressed thousands of therapeutics that we use today, it is not without its experimental and ethical downfalls.

Animal Testing 52

Animal Testing Pharma Companies Laboratories Drug Development 52

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. The guidance notes that all approaches should be justified.

Trials 40

Trials Marketing Clinical Trials Regulations 40

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

Broad Institute

JUNE 27, 2024

Delivering genes into the human brain is challenging; many clinical trials have used adeno-associated viruses (AAVs) as gene-delivery vehicles, which are small and can only contain a small amount of genetic code. However, with a strong therapy design and promising laboratory results in hand, the researchers have good reason to be hopeful.

Disease 142

Disease Therapies Engineering Clinical Trials 142

Drug Target Review

OCTOBER 3, 2024

Moreover, ethical considerations regarding the use of laboratory animals further complicate the use of primate polyclonal serum, and successful immunisation is not always guaranteed. FDA no longer needs to require animal tests before human drug trials [Internet]. 1975 Aug;256(5517):495–7. 2024 Jan 5;16(1).

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

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