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The momentum for electronic data capture (EDC) usage in clinical trials is now beyond the tipping point and should continue to speed up, says Anthony Costello, vice president of Nextrials.
Apotex, the largest Canadian-owned pharmaceutical company, has selected Sparta Systems’ TrackWise web-based software platform to capture and track all regulatory information required for new products and the entire span of product lifecycle management.
Skilled use of outsourcing can save FDA-regulated life sciences companies money, time and headache, but it doesn't absolve them of ultimate responsibility for their product and data, former FDA Special Assistant to the Associate Commissioner for Regulatory Affairs and now EduQuest President Martin Browning said at an Aug. 31 audioconference sponsored by FDA News.
Human-implantable radio frequency identification (RFID) chip manufacturer VeriChip recently made the first sale of its radio frequency (RF) infant protection system in Canada and is in talks with the U.S. military about another under-the-skin chip.
Human-implantable radio frequency identification (RFID) chip manufacturer VeriChip recently made the first sale of its radio frequency infant protection system in Canada and is in talks with the U.S. military about another under-the-skin chip.
The FDA announced it has entered into a three-year agreement with two national institutions to facilitate the development and regulation of nanotechnologies for research and cancer treatments, but one critic asserts the agency also needs to take similar actions for OTC products.
The FDA has formed an internal Nanotechnology Task Force to help the agency further understand this emerging science and determine how to regulate as well as encourage the development of products that use it.
Carefully defining the scope of an esubmissions program and having cross-functional agreement is "vitally important," Octagon Research Solutions Principal Consultant Gareth Williams told PIR last week.
Seattle-based biotech company Dendreon partnered with Oracle to help it manage the manufacture and distribution of patient-specific cancer treatments in its clinical trials, document regulatory compliance and ensure the security of patient edata, a company executive told PIR last week.
The FDA is partnering with the Massachusetts Institute of Technology (MIT) to develop new databases to improve the agency’s postapproval drug and medical device monitoring, a high-ranking FDA official said Aug 17.