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The FDA expects to collect $312.2 million in generic drug user fees next fiscal year, with companies paying slightly less for each ANDA filing and facilities that produce active pharmaceutical ingredients and finished generic products paying more. Read More
Generics manufacturers seeking product approvals in the European Union can opt to share the resulting application reviews with regulatory bodies outside the bloc under a pilot program designed to coordinate drug approvals across international borders. Read More
Complaints of particulates found in vials of nine lots of Cubist Pharmaceuticals’ anti-infective drug Cubicin prompted the company to initiate its second recall of the drug in as many days. Read More
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than stage by stage, which is the current policy. 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 has given Mapp Biopharmaceutical its blessing to send two additional doses of its experimental ZMapp Ebola monoclonal antibody to Liberia, after agency officials facilitated communication between the drugmaker and Liberian health officials. Read More
Industry groups are pressing for dialogue with Indian regulators after the Delhi High Court declined to stay a government order establishing price controls on formulations used in 108 nonscheduled drugs for diabetes and cardiovascular disorders. Read More
The EU’s drugs authority is advising manufacturers that routine inspections will now include a focus on compliance with pharmacovigilance reporting requirements. Serious violators will face the Pharmacovigilance Risk Assessment Committee. Read More
Countries in the Caribbean are working to establish a unified registration process for generic drugs, an effort aimed to improve the quality, availability and access to essential therapies. 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