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

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. Published online September 27, 2023. Troubador Publishing; 2023. doi:10.1001/jama.2023.14443

Animal Testing 147

Animal Testing Disease Trials Research 147

Drug Discovery World

JANUARY 21, 2024

Bushell will discuss the history and technological underpinnings of induced proximity, the lessons learned from the PROTAC (proteolysis-targeting chimeric) example, and how technology can create enhancement-targeting chimeric, or ENTAC, drugs and fully realise the potential of targeted protein enhancement. Is pharma’s commercial model dying?

Vaccine 130

Vaccine Computational Chemistry Animal Testing Engineering 130

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. With over 150 pharma services/supply companies and 19 universities, Scotland is one of the most advanced life science sectors in the UK and the world.

Research 130

Research Virus Drugs Disease 130

Vial

MAY 20, 2024

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. The two broadest categories of drug development can be separated into the preclinical and clinical research stages. over this period.

Clinical Research 52

Clinical Research Research Clinical Trials Laboratories 52

Drug Target Review

SEPTEMBER 26, 2023

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. 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 110

Drugs FDA Disease Animal Testing 110

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