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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
FDA efforts to standardize capsule and tablet sizes for generic drugs are unnecessary and will strain relationships with suppliers, generic drugmakers say. Read More
The White House on March 4 proposed increasing funding for the FDA in fiscal 2015 by eight percent above fiscal 2014, a slight bump that includes a $6 million increase in GDUFA user fees. Read More
The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. Read More
Beginning with the 2015/2016 flu season, drugmakers producing vaccines in the EU to protect against annual flu strains will not need to conduct preapproval clinical studies to support vaccine applications. Read More
An FDA report using new data collection methods shows that more drugs than previously thought need to meet their postmarketing requirements and postmarketing commitments, which include Phase IV clinical trials. Read More
The European Medicines Agency is asking sponsors to give two months’ advance notice of their intent to file orphan drug applications to help the agency meet its 90-day review deadline. Read More
Sponsors may be asked to provide the European Medicines Agency with additional data from failed trials to hone in on subpopulations where the treatment may be effective. Read More