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Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format, allowing for cost savings and potentially swifter reviews. 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
The Scottish Medicines Consortium plans to launch a new initiative on patient-centered research, giving patient groups and clinicians a stronger voice in how drugs for life-threatening and rare diseases are developed and approved. Read More
The FDA and India’s Ministry of Health and Family Welfare signed a five-year accord that will allow them to share information from clinical trial inspections in their respective jurisdictions. Read More
Drugmakers are urging the FDA to publish extensive guidance on even the most basic issues related to clinical trial diversity as the agency steps up its efforts to increase diversity in clinical trial subject populations. Read More