We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA wants drugmakers to use clinical remission as their primary endpoint when conducting trials for short-term ulcerative colitis therapies. Read More
The FDA is simplifying the process of developing written procedures for an IRB, providing industry with a comprehensive checklist that satisfies both FDA and HHS requirements. Read More
The number of cardiovascular drugs entering the clinical development pipeline has been declining since 1990, according to a study evaluating public data from over 4,000 trials. The decline was seen across Phase I, II, and III clinical trials. Read More
The cancer moonshot’s blue ribbon panel made 10 recommendations to the National Cancer Advisory Board to guide scientific direction for the national research initiative, specifically organizing an immunotherapy clinical trials network. Read More
When planning an international clinical trial, setting endpoints that are clinically meaningful across regions and planning ahead for local factors are recommended in draft FDA guidance. Read More
Better communication with states is needed when the FDA stops a drug compounder from operating, the agency said in a new set of recommendations. Read More
The FDA is taking public questions and comments relating to implementing a global guidance from 2010 on the nonclinical evaluation of anticancer drugs, also known as the S9 guidance, developed by the International Council for Harmonisation. Read More
A joint meeting of three FDA advisory committees tackled the issue of prescribing opioid painkillers in pediatrics, and came up with a constant refrain: We need more data. Read More
New Mexico Attorney General Hector Balderas has filed a lawsuit against Bristol-Meyers Squibb, alleging the company engaged in false and deceptive marketing of its blood thinner Plavix. Read More