Clinical Trials Development Drug Trials FDA Approval 
XTalks
AUGUST 4, 2022
Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.
Drug Discovery World
MAY 21, 2024
Modern experimental procedures, such as immunisation, B-cell screening, and synthetic library generation, have been pivotal in developing approximately 80 FDA-approved antibody therapeutics. These targets, along with many others, are universally deemed as ‘difficult-to-drug’ targets.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Drug Discovery World
NOVEMBER 29, 2023
Researchers have created a mathematical model that can accurately depict Alzheimer’s disease progression in individual patients, paving the way for personalised treatment and faster development of therapies. These findings closely matched the results of the corresponding real-life clinical trials.
Advarra
AUGUST 16, 2022
Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. FDA Expedited Programs.
Drug Discovery World
MAY 3, 2023
Patients with diabetes mellitus have an increased risk of cardiovascular events and endothelial dysfunction is an important factor for this development” said Jan Nilsson, Professor in Experimental Cardiology, Lund University, and principal investigator in the trial.
FDA Law Blog
MAY 3, 2021
On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §
Delveinsight
AUGUST 13, 2021
Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. Why the Need?
Expert insights. Personalized for you.
52 
Let's personalize your content