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GPhA is putting forward a compromise naming scheme for biosimilars that it hopes will quell the dispute over how to assign international nonproprietary names (INN) to follow-on biologics. Read More
The FDA has slapped Institut Biochimique SA (IBSA) and Akirmax Pharmaceuticals with an untitled letter for omitting risk information and important contraindications on a Facebook page promoting the hyperthyroid drug Tirosint. Read More
The European Medicines Agency (EMA) on Tuesday launched its latest transparency effort, publishing the first of many summaries of drugmakers’ risk management plans (RMP) that it plans to make available throughout 2014. Read More
Generic drugmakers in the EU must create a program to assess the effectiveness of their risk minimization efforts for each marketed drug, EU regulators say. Read More
Beginning on June 16, whenever a drugmaker receives approval for a generic drug by an EU member state, it will have 15 calendar days to report the approval to the EMA’s new centralized electronic registry. Read More
The FDA is telling drugmakers not to file supplemental applications for minor postapproval manufacturing changes such as swapping excipient suppliers, moving a manufacturing process within a plant or removing coloring or flavoring ingredients from a drug. Read More
Baxter and Sagent Pharmaceuticals are the latest generic drugmakers to recall products with leaky containers, notifying healthcare providers that affected product may be contaminated with particulates. Read More
New GOP-proposed legislation aimed at curbing prescription drug abuse would require certain generic drugmakers to conduct background checks and perform drug testing for employees with access to controlled substances. Read More
The EU’s new pharmacovigilance law could cost generic drugmakers fees totaling as much as $330,000 for each drug they make to cover postmarketing assessments. Read More
The FDA on Feb. 25 released new information that shows the scope of its efforts to investigate the efficacy and bioequivalence of generic drugs, publishing summaries of ongoing research. Read More
Indian generics makers Sun Pharma and Ranbaxy are both facing individual Class II U.S. recalls related to product mixups. Both recalls were included in the FDA’s March 5 enforcement report. Read More