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The European Medicines Agency has backed off of several controversial limitations it was considering imposing on sponsors of trials for treatments for chronic primary immune thrombocytopenia. Read More
Shortly after the EMA announced it would consider redacted clinical trial reports in its proposed transparency plan, AbbVie said it was dropping two lawsuits against the agency. Read More
Sponsors of BLAs, NDAs, and ANDAs should justify the amount of excess medication for injectable drug products they plan to pack in vials and ampules, according to an FDA draft guidance. Read More
While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More
The European Medicines Agency is planning a series of May meetings with industry to unveil the process it plans to use to determine whether clinical trial data is considered confidential under its new transparency rules or whether it must be disclosed. Read More
The FDA wants manufacturers of low molecular weight heparin (LMWH) products to do a better job of assessing immunogenicity risk before submitting their products for approval. Read More
Drugmakers and non-profit collaborators are releasing the results of failed cancer trials so that researchers can examine the datasets to look for signals or other useful information that may suggest new research directions. Read More
The UK’s pharma regulator Monday began accepting applications for its Early Access to Medicines Scheme to allow not-yet-approved drugs for life-threatening diseases quicker interim approvals so they can be distributed to patients. Read More
Drugmakers decried the FDA’s push for sponsors of new chronic pain treatments to submit more safety data, calling it inconsistent and confusing. Read More
While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More