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India’s medicines authority Wednesday detailed a proposed set of steps drugmakers must take to schedule presubmission screening meetings with drug reviewers — codifying an informal system that was launched several years ago. Read More
The House Energy & Commerce Committee that oversees the FDA is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight, give industry incentives to find new uses for old drugs and expand U.S. drug manufacturing. Read More
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. Read More
The European Medicines Agency appears to be backing off promises to protect industry trade secrets in its new clinical trials database, and is developing scenarios under which it would release commercially confidential information. Read More
Several EU member states suspended marketing authorization for therapies that underwent bioequivalence testing at contract research organization GVK Biosciences’ facility in Hyderabad, India, citing serious concerns about deviations from good clinical practice. Read More
Mobile health programs can unburden clinical trial sponsors and investigators by streamlining procedures, eliminating unnecessary activities and reducing site visits, according to GlaxoSmithKline and Medidata. Read More
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