In June 2012, the United States Food and Drug Administration will pilot a program allowing medical device manufacturers to submit ISO 13485:2003 quality system audits to satisfy the FDA 21 CFR Part 820 inspection requirements for one year.
Drug and device makers have asked for regulators to issue rules on the use of social media. Earlier this year, the FDA issued a draft guidance to address how companies should respond to certain requests for information on off-label use of products. Although the draft guidance will not give the device and drug manufacturers a roadmap to navigate social media sites such as Twitter and Facebook, it does provide some direction on how companies should process without getting in trouble with regulators.
The Central Management Committee (CMC) on Medical Devices, formed in 2010 to improve the effectiveness of regulations in the EU, has issued a decision on medical device labeling.
There was an interesting article in the Times of India this week. It appears that there has been some fallout over certain CROs using patients that were not completely aware of the clinical trial they were entered into. Indeed, the vast majority of them it seems were actually illiterate. Illiterate & poor. Somehow, I do not believe that this is the first time the most vulnerable of society has been taken advantage of.
Five of the 12 registered CROs in India have formed an alliance (AP CRO) to build a greater awareness of ethical practices in the research community. Continue reading »
The U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices.
At the end of July, the FDA announced it had released a new guidance document that clarifies the rules about when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
Once the announcement that the FDA was updating the 510(k) process, many medical device companies began the long wait for the final guidance to be published. The process has been a long one; with industry experts, politicians and the FDA weighing in on the final result. Continue reading »
Reporting Adverse Events and Serious Adverse Events
Central Drugs Standard Control Organization New Delhi (CDSCO) issued their guidelines for reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs) in May 2011. Much like the FDA, they describe AEs as any untoward medical occurrence (including a symptom/disease, adverse reactions, or an abnormal laboratory finding) during treatment with a pharmaceutical product in a patient or a human volunteer that does not necessarily have a relationship with the treatment being given’. They also describe SAEs as ‘An AE that is associated with death, inpatient hospitalization (in case the study was being conducted on out-patients), prolongation of hospitalization (in case the study was being conducted on in-patients), persistent or significant disability or incapacity, a congenital anomaly or birth defect, or is otherwise life threatening’. So we are comparing apples with apples here when we use the FDA as the benchmark. Continue reading »
Recently I’ve had some discussions with a Sponsor about whether Cognitive Debriefing subjects need to be in the specified trial disease state. Can we use healthy, non-disease state interviewees in this process?
Cognitive Debriefing (CD), also known as Pilot Testing, is part of a translation process where people are invited to review a recently translated, validated Quality of Life (QoL) instrument Continue reading »
Structured authoring. Controlled English. XML. CMS. TMS. DITA. Workflow. FrameMaker is great. FrameMaker is terrible. XML is the way to go. XML is so far out of our reach. Translation memories. Translation glossaries. Like sugarplums dancing in your head, right?
Wrong.
There is so much information out there regarding source content creation and translation that it really boggles your mind. Continue reading »
