Simplifying Global Compliance
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.
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
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 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
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
Generics makers want an equal say at the highest echelon of the standard-setting International Conference on Harmonization. Read More
To improve ANDA submissions, the FDA should spend more time with generics companies before they file an application, as is done with brand manufacturers in the run-up to an NDA, the Generic Pharmaceutical Association says. Read More
The FDA is mulling changes to the way it determines eligibility for 180-day generic exclusivity, including opening up the exclusivity decision-making process to the public, and it’s inviting industry to offer feedback on the idea. Read More
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