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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
Iroko Pharmaceuticals’ low-dose painkiller Zorvolex is now available for patients with osteoarthritis pain, following FDA’s approval for the second indication. Read More
The FDA has warned four generic drug manufacturing facilities that they haven’t paid their GDUFA fees for the last two fiscal years, meaning all of their products are automatically misbranded. Read More
The FDA has shed light on how amendments to an NDA, BLA or supplement may affect review timelines established under the 2012 prescription drug user fee program. Read More
New Jersey-based Eisai is suing the FDA over the exclusivity clock assigned to two of its products, claiming the government arbitrarily shortened its five-year exclusivity period from generics competition. Read More