FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. 42 U.S.C. § 262(k)(2)(A)(i)(I).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Discovery World

MAY 25, 2023

Following the Scottish Research and Drug Development Forum meeting, DDW’s Diana Spencer provides a snapshot of drug discovery in Scotland. Introduction to the CRUK Beatson Institute The first speaker was Professor Owen Sansom, Director of the Cancer Research UK Beatson Institute, who gave two presentations.

Research 130

Research Virus Drugs Disease 130

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. What is a Pre-Clinical CRO? The global preclinical CRO market was estimated to be valued at US$5.7

Clinical Research 52

Clinical Research Research Clinical Trials Laboratories 52

Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development. After all, these failures come on top of decades and decades of research into these diseases.

Animal Testing 147

Animal Testing Disease Trials Research 147

Drug Discovery World

JANUARY 21, 2024

Inspired by the overall event theme of ‘Innovation at Every Turn’, the DDW track will present leading research and case studies from experts in academia, government agencies and the industry on how technology is innovating from bench to bedside, lab to patient. It is sponsored by Integra Biosciences and Hamamatsu Corporation.

Vaccine 130

Vaccine Computational Chemistry Animal Testing Engineering 130

Drug Target Review

SEPTEMBER 26, 2023

Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

Drugs 109

Drugs FDA Disease Animal Testing 109

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