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The FDA has expanded its list of priority generics applications to include ANDAs filed under government purchasing programs and applications from filers that claim “extraordinary hardship.” Read More
European regulators are asking drugmakers to submit information on products that were part of bioequivalence trials conducted at contract research organization GVK Biosciences’ India facility, after an inspection raised serious concerns about good clinical practice compliance. 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
A patient advocacy group is using a recently created pathway for challenging generic drugs through the U.S. Patent and Trademark Office to contest the patent on Wyeth’s antibiotic Tygacil outside a Hatch-Waxman ANDA. Read More
Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. Read More