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India’s Ministry of Health and Family Welfare has begun publishing data about drugmakers’ payouts in cases where clinical trial subjects died during a trial. 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
PhRMA has asked the Office of the U.S. Trade Representative to put the EU on notice for its plan to publish clinical trial data that currently is treated confidentially. Read More
The FDA wants sponsors submitting bioavailability (BA) and bioequivalency (BE) data in support of an orally administered new drug to conduct pharmacokinetic studies of their products. Read More
Northwestern University may have withheld information during a Senate probe on the use of an unapproved heart device, a key lawmaker claims in a new letter to the university and its hospital. Read More
The FDA is asking sponsors of BLAs, NDAs, and ANDAs to justify the amount of excess medication for injectable drug products they plan to pack in vials and ampules. Read More
Purdue Pharma is reporting positive results for an investigational once-daily analgesic that could compete with Zogenix’s controversial painkiller Zohydro ER, which, unlike Purdue’s candidate, lacks abuse-deterrent properties. 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
The FDA is asking sponsors of antiretroviral drugs to submit clinical trial data sets that include patient, endpoint, genotypic and phenotypic data when reporting on HIV-1 resistance in support of the drug. 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
India’s Ministry of Health and Family Welfare has begun publishing data about drugmakers’ payouts in cases where clinical trial subjects died during a trial. The first wave of data focuses on payouts between 2010 and 2013. 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