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Clinicians, bioethicists and regulators disagree over whether or not some patients in Ebola drug trials should be given placebos, and the debate is pitting the FDA against some international organizations.
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Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says. Read More
Clinical trial sponsors and contract research organizations incur the majority of good clinical practice violations, a European Medicines Agency panel reports. Read More
Sponsors of multisite clinical trials should take greater advantage of their ability to use a single institutional review board, according to a draft policy that requires the practice for all NIH-supported domestic trial sites. Read More
Indian authorities issued a number of clinical trial regulations last month, covering compensation for trial injuries, exemptions for local Phase III trials and penalties for conducting trials without permission. Read More
In two years’ time, manufacturers must submit applications for NDAs, ANDAs, INDs and BLAs using a set of approved electronic formatting standards, which the FDA finalized last month. Read More
Regulators, sponsors and clinical investigators wrestled with trial data transparency and reporting requirements for the second year in a row, with the European Medicines Agency trying to pin down the most effective ways to require sponsors to share the results of their studies. U.S. officials were primarily concerned with stimulating development of new antibiotics, encouraging sponsors and investigators to more deeply analyze subgroup outcomes and promoting the use of biomarkers in drug trials. Read More
An updated FDA guide on electronically submitting clinical study data, released last month, clarifies a number of requirements for preparing data sets and reviewers’ guides. Read More
The FDA is requesting industry feedback on the burdens related to its regulation of clinical safety and efficacy trials of unapproved new drugs and biologics. Read More
A coalition of pharma companies and medical researchers is proposing a framework for determining authorship of clinical trial publications, with the aim of increasing transparency and public trust in medical research. Read More
India’s Central Drugs Standard Control Organization has a released a draft document outlining accreditation and ethics standards for clinical trial sites, investigators and ethics committees. Read More
Future FDA guidance on developing drugs for specific indications will include key milestones to help manufacturers plan their product development programs and guide potential talks with the agency’s review division. Read More