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The FDA is making available a new tool to help it receive and process electronic device, drug and biologic applications in an effort to keep up with industry’s use of internet submissions.
The FDA Aug. 11 said it is seeking comments on how a unique identification system for devices might reduce medical errors, facilitate recalls and improve adverse event reporting.
Electronic data capture (EDC) in clinical trials offers a host of benefits for sponsors if done properly, an expert said at a recent FDAnews audioconference.
The FDA is in disarray, beset by political and industry influences and hampered by insufficient funding to protect public health, a study of agency scientists concludes.
The FDA recently approved MedImmune’s supplemental biologics license application to use a new technology to develop two influenza vaccines, according to the company.
There is growing consensus that doctors need to work more closely with heart device manufacturers to establish guidelines for managing patients implanted with devices at risk for malfunction.
It’s just a matter of time before drug, device and biologics companies see the value in RFID and embrace the technology to improve product quality, speed recalls and work more efficiently and effectively with regulators, IBM’s RFID guru told PIR.
Standards are mature enough now for businesses to embrace electronic data capture (EDC) and feel the positive impact almost immediately, Fast Track CEO Ed Seguine told PIR.
A key strategic necessity for effective IT governance and compliance is the ability to integrate, automate and centralize the process controls implemented by the organization, says a new IBM white paper.
Large drug manufacturers continue to be the big drivers behind the broadest electronic document control (EDC) initiatives, as evidenced by several presentations at the recent DIA conference in Philadelphia.