Simplifying Global Compliance
EU officials continued to show their willingness to meet drugmakers halfway on new plans for publication of clinical trial reports. 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
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amount of excess medication for injectable drug products they plan to pack in vials and ampules, according to an FDA draft guidance.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
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
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
The FDA should incentivize sponsors to include minorities and other underrepresented groups in clinical trials and delay approving products whose evidence is based on less-inclusive trials, activists say. Read More
Drugmakers balked at the FDA’s push for sponsors of new chronic pain treatments to submit more safety data, calling it inconsistent and confusing. Read More
Supportive data gathered from two definitive clinical trials may be sufficient to establish efficacy for drugs proposed to treat chronic fatigue syndrome/myalgic encephalomyelitis, the FDA says. Read More
FDA inspectors berated a clinical investigator at New York’s Columbia University Medical Center for failing to properly oversee a clinical trial, despite the university having shut down the study after discovering the violations. Read More
The FDA is asking sponsors of INDs, NDAs and NDA supplements to submit bioavailability and bioequivalency data from pharmacokinetic studies of their products. Read More
The European Medicines Agency last month launched a pilot program to speed new therapies to patients by authorizing products in stages for targeted populations. Read More
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