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The European Medicines Agency has confirmed plans to halt sales of 700 drug forms and strengths authorized based on clinical studies performed by Hyderabad, India-based GVK Biosciences. Read More
Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, the Chinese regulators say. Read More
Drugmakers are getting better at reporting clinical trials results in a timely manner, with only 10 percent of studies on new treatments approved by the European Medicines Agency in 2012 not disclosed within 12 months, a new study shows. Read More
The U.S. FDA’s device center is taking steps to improve the predictability of IDE reviews with the establishment of a new director-level position to oversee the clinical trials in the Office of Device Evaluation, a center official says. Read More
The FDA issued Rockville, Md.-based CXL-USA a warning letter for failing to get agency approval before starting a clinical trial and for lax monitoring of the study. Read More
New guidance on extrapolating existing data to gain approval for pediatric indications applies to new devices as well as those already approved for adult use, an FDA official says. Read More
CRO Analytics and the Association of Clinical Research Professionals are partnering to develop a more holistic approach to clinical trial site quality. Read More
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
Sponsors looking to determine whether their drugs have impurities that might lead to cancer-causing mutations in human DNA should conduct two toxicology assessments using mathematical models that base this probability on the drug’s chemical structure. Read More
The FDA wants sponsors of investigational drugs and biologics to use the Logical Observation Identifiers Names and Codes to identify laboratory results from clinical studies in regulatory submissions, and is asking for suggestions on how it might assist firms in adopting the codes. Read More
Devicemakers that want to ensure enough women participate in their clinical trials should set a clear and prespecified goal and stick to it, experts say. Read More