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.
Sponsors conducting clinical trials in India must fully inform study patients about potential payments resulting from adverse events during videotaped informed consent sessions, a draft guideline says. Read More
The level of detail required in sponsor declarations regarding ongoing research should be proportionate to the risk associated with the research being conducted, the UK’s Health Research Authority says. Read More
The FDA wants IND sponsors to stop routinely using age limits as exclusion criteria for clinical trials and increase the number of patients with multiple chronic conditions included in drug studies. Read More
A new report from PricewaterhouseCoopers claims that value and volume of pharmaceutical mergers and acquisitions increased in the last quarter of 2013. Read More
Lawmakers are asking the White House Office of Management and Budget (OMB) to wrap up its review of a proposed rule that would require electronic package inserts for prescription drugs and biologics, saying the implementation blueprint is long overdue. Read More
The U.S. experienced 38 drug shortages during the first three quarters of 2013, a substantial drop from 2012 when 117 drug shortages were reported, according to FDA figures released Friday ahead of a scheduled House hearing on the issue. Read More
Companies producing vaccines in the EU to protect against annual flu strains will not need to conduct pre-approval clinical trials to support vaccine applications beginning with the 2015/2016 flu season. Read More
Shire said Thursday it will abandon the development of its blockbuster hyperactivity drug Vyvanse as a treatment for major depressive disorder after two failed Phase III trials. Read More
To discourage GMP scofflaws, the European Medicines Agency is now publicly naming drugmakers that aren’t in line with current good manufacturing practices. Read More