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Starting next year, drug companies seeking to market products in Canada will need to provide the regulatory authority with information on proposed names, labels and packages.
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A public-private partnership in the EU plans to spend $4.5 billion over the next decade to boost, by 30 percent, the success of clinical trials on high-priority drugs. Read More
European authorities say there is not enough evidence to conclude that emergency contraceptives lose their effectiveness in women weighing 165 pounds or more, as one manufacturer had cautioned in its product labeling. Read More
The French National Assembly last month approved a proposal that would allow doctors to use less expensive off-label drugs even if an approved therapy exists — sparking cries from European drugmakers that the government is placing cost savings over patient safety. Read More
Pharma is seeking greater clarity around a European Medicines Agency initiative to streamline regulatory approvals of drugs and national coverage decisions via parallel reviews by the EMA and health technology assessment bodies. Read More
Drugmakers are praising a decision by Ireland’s Health Products Regulatory Authority to allow as many as three dozen drugs to be sold through pharmacies without a prescription. Read More
The European Medicines Agency acted properly in rejecting a UK-based pharmaceutical company’s over-the-counter migraine medicine, the European ombudsman says. Read More
Australia’s Therapeutic Goods Administration is now following Europe’s lead on drug safety oversight in both general and pediatric populations. Read More
Two years after the EU implemented landmark pharmacovigilance legislation, the European Medicines Agency is offering drugmakers and other interested parties a comprehensive look at how the region’s drug safety system actually operates. Read More
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities. Read More