As the Food and Drug Administration (FDA) transitions between commissioners, continues negotiating industry user fee commitments and prepares for a possible legislative overhaul, a major transformation is in the works for the agency over the next couple of years. (RAPS, Regulatory Focus).
Califf seeks new “ecosystem” for clinical trials
www.appliedclinicaltrialsonline.com
Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new deputy commissioner for medical products & tobacco, Robert Califf. (Applied Clinical Trials)
Secret formula to be the best clinical trial site
The best clinical trial sites are empowered. The best clinical trial sites have laser-focus on the ultimate goal to advance treatment options for their patients. (ClinOps Toolkit)
Qualcomm’s Capsule wins FDA nod for patient monitoring system
Qualcomm (NASDAQ:QCOM) medical data management subsidiary capsule Tech said it received 510(k) clearance for its SmartLinx Vitals Plus patient monitoring system. (Massachusetts Device)
Human Longevity appoints head of regulatory affairs and policy
Human Longevity (HLI), the genomics-based, technology-driven company, has announced that Sally Howard, J.D., has been hired as head of regulatory affairs and policy. Howard, who has more than two decades of health policy and regulatory expertise, will lead all efforts related to federal and state regulatory oversight for HLI. (CenterWatch News Online)
Trends in global clinical trial registration
The number of clinical trials registered globally increased from 3,294 in 2004 to 23,384 in 2013, according to new research published in BMJ Open. (AllTrials)
Pressure group floats idea of government-backed clinical trial awareness campaign
The Coalition for Clinical Trials Awareness (CCTA) has called for a federally-supported public health campaign to make people more aware of drug research and the value of participating in studies. (Outsourcing-Pharma.com)
Data mining as a path to better trial design
The prospects of Big Data are tantalizing for the life sciences industry, but there’s still much left to do with small data. (Geeks Talk Clinical, Medidata Solutions)
Novartis joint venture helps virtual trial CRO to $6.5 million fundraising round
Science 37 has raised $6.5m (5.7m pounds) from Lux Capital and dRx capital, the fund set up by Novartis and Qualcomm, to advance its virtual clinical trial service business. (Outsourcing-Pharma.com)
Seek 1 million U.S. citizens
The U.S. National Institutes of Health (NIH) will start enrolling 1 million or more U.S. citizens as the first key step to implementing President Obama’s nationwide Precision Medicine Initiative (PMI). Plans for the clinical research cohort were outlined in September by the NIH Advisory committee. ($. Nature Biotechnology)
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