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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
The European Medicines Agency has officially launched an electronic database for the safety reports all drugmakers are required to periodically submit on approved therapies. Read More
The FDA warned Thursday that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More
The European Medicines Agency has published a 100-page technical guide aimed at helping drugmakers comply with a new global standard on the reporting of individual case safety reports. Read More
Last year saw major strides in increasing transparency around clinical trial data in the EU and trial safety and compensation in India. An international group also set the gears in motion for a harmonized guideline on multiregional clinical studies.Read More
Concerns over potential heart risks have prompted the UK’s Medicines and Healthcare products Regulatory Agency to reclassify the anti-inflammatory drug diclofenac from OTC to prescription-only in tablet form. Read More
The FDA in 2015 plans to begin work on a nationwide network of electronic health records and insurance claims data it will use to investigate drug safety questions that emerge from adverse event reports or other sources. Read More
The FDA in 2015 plans to begin work on a nationwide network of electronic health records and insurance claims data it will use to investigate drug safety questions that emerge from adverse event reports or other sources. Read More