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According to the article, Commissioner Hamburg stated the following in a recent meeting:
Drug companies know how difficult it can be to develop a solid risk evaluation and mitigation strategy (REMS). In fact, the process can be so difficult that even those assigned to develop the strategy spend much of their time confused about what it is that the FDA wants/requires in a REMS.
During 2010, the FDA performed a large number of regulatory inspections and has compiled a list of the most common deviations found. According to www.labcompliance.com, 19 percent of the devations found on the list were "related to unvalidated lab test methods," and that "laboratory controls [issues] ranked as number 1." Additional data points of interest also include quality system and production process control systems which rank at 9 percent and 6 percent respectively. Also according to labco
On February 8th of this year the FDA announced Innovation Pathway, a new program dedicated to the priority review of new medical devices. The first submission selected for the program is an upper-extremity prosthetic that is controlled by the brain. This device is a pilot and will help determine the efficacy of the program. The FDA will also ask for additional public comment regarding the program before it is implemented on a widespread basis.
Did you know that the FDA has proposed a unique device identification system for medical devices?
The path to market for software that is to be used with medical devices can be rigorous. The FDA recently announced (Feb. 14, 2011) a "less burdensome path to market" according to FDA News.1 These systems (i.e, software and hardware combined) are known as Medical Device Data Systems (MDDS) and have been recently defined as low-risk devices or "Class I" devices, which definition relieves medical device professionals of the immense effort required during premarket review. However the MDDS systems
This article has been reprinted with permission from RPM Report.
"For FDA, innovation is not just about new ideas, but it is about making sure that those new ideas truly translate into the products and opportunities that people need and count on," Commissioner of Food and Drugs, Margaret Hamburg, explained in her opening address at FDLI's 54th Annual Conference.
The Food and Drug Administration's (FDA) Sentinel Initiative was launched May 2008 in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA).1 The FDAAA provisions mandated that the FDA take the lead in developing an electronic surveillance system to increase the agency's capacity to monitor regulated medical products on the market. Although the FDA has a number of systems already in place to track adverse events and product problems, these monitoring tools all represent a p
As reported by FDANews, the Safe Use Initiative is an important step toward lowering avoidable medication risks.
Too often, medical device innovators develop their regulatory submission strategy near the end of the product development process, rather than at the start. They often make launch date commitments without considering important regulatory submission issues, such as product efficacy claims and testing to support those claims.
The proposal—whether it will soon be implemented or not—has manifested the obvious drive FDA has toward automated systems. For example, once FDA is fully automated industry will have two options for electronic submission of MDRs including one for low volume reporting and another for its high volume counterpart. Industry will also benefit by "doing business" with an agency that will be far more efficient in terms of data collection, response, feedback and analysis. Those benefits alon
The Food and Drug Administration (FDA) launched its Safe Use Initiative in November 2009 to take a more proactive role in reducing the risk of patients suffering unnecessary injuries due to medication use. Following an in-depth analysis of both unavoidable and manageable medication risks, the agency concluded that steps needed to be taken to establish a formal, coordinated system to protect the public from preventable harm caused by medication use. FDA's report, FDA's Safe Use Initiative: Collab
That under key FDA regulations, requirements pertaining to nonconformance disposition are directly related to CAPA requirements?
According to a recent article1, the FDA is taking inspections in countries outside the U.S. more seriously than ever before. So seriously in fact that overseas inspections are likely to rise by as much as 50 percent.
The FDA is currently implementing numerous systems which promise to usher in a new era of electronic interactions between the agency and its constituents (i.e. industry and consumers).
The FDA Pilot program, created in 2005, was designed to allow sponsors to demonstrate their understanding of the eCTD and their ability to create a technically valid sample submission. The sample submission should be representative of the final eCTD dossier and should, at minimum, include navigational items for all modules. When compiling the Module 4 and 5 Study Report, the sponsor should also demonstrate their understanding of the study data specifications, e.g. study tagging files. Once submi
Did you also know that your CAPA system relies almost entirely--at least initially--on the effective management of events such as nonconformances and deviations?
There was frantic activity in Europe during May 2008 following the publication of a discussion document on the recast of the Medical Devices Directives that sparked a hot debate on the future of medical regulation in Europe. The recast did not reject the new approach but the European Commission are concerned--amongst many other items--about the consistency of notified body performance, market surveillance, and vigilance; however, these were also issues raised in the Revision of the Active Impla
According to an article by José Manuel Barroso and Günter Verheugen (President and Vice President, respectively, of the European Commission), the commission's ongoing campaign "to cut the regulatory red tape" will use electronic solutions to boost international trade, saving European businesses 2.5 billion per year when fully operational.
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