Always have local copies of your dataThe above is why it is a bad idea to put your fate in someone else's hands when you have a choice. By default, keep your data processing and data stores local, and then use cloud services when they suit you. All these kiddies...
FDA Recalls is an iPhone and iPod iTouch application that provides you with access to the US Food and Drug Administration FDA recall database. It features recalls fetches new FDA recalls when opened, view recall details and description, find out more detailed info about the recall from the FDA website,...
HHS Health and Human Services News Reader grabs the top stories from Health and Human Services and delivers them to your iPhone or iTouch. The news feeds covers HHS News, Hurricane PSAs, Pandemic Flu news releases, FDA press releases, FDA recalls, food and cosmetics announce, cements, science selections, avian influenza,...
Food and Drug Administration FDA News Reader grabs the top stories from the FDA and delivers them to your iPhone or iTouch. The news feed covers news releases, recalls, enforcement reports, consumer health information, center for devices and radiological health, center for Drug Evaluation and Research, center for Food Safety...
Pharmaceutical companies operate in one of the most highly-regulated industries in the world. As most companies sell to a global market they have to manage compliance with an increasing set of regulations around the world - most importantly the FDA regulations, such as FDA 21 CFR Part 11, if the...
The Cheerios KerfluffleUltimately General Mills will winAs long as their claims are true and they can back it up and they say they can, ultimately the government cannot stop General Mills from making the claim. General Hills may have to jump through some legal hoops to do so, but the...
A comment to one of my recent posts said: "Hey you wanna do a story? Try researching Teflon and what the FDA's special group studying it has been up to and what the manufacturer has been doing. Then think about all the teflon coating in fast food, popcorn and cooking...
Certification the tip of the health reform spearIt's difficult to move into new areasWhen the money controls the market entry.I'm in agreement with the need to displace the old approach as it certainly doesn't help us, as individuals or doctors or clinics/hospitals.One factor of interest to me is that the...
FDA orders new approvals on old medical devicesYet another agency failing at its job. I am glad they are fixing it.but waiting 30-40 years? Thats just plain failure to do your job. Yet again a manufacturer says "trust me" and the goverment says goofy voice "ok".Where I...
So what we're left with is risky devices that were never tested but lie beyond the reach of civil law because courts claim the untested approval is binding. The new round of tests will close the loophole. by Dana Blankenhorn
Internet pop-ups generally contain little text space, and are designed to encourage click-throughs to larger ads on drug makers' Web sites which do have space for warning information. If warnings must appear on the pop-ups themselves it is hard to see how they remain a viable Internet medium. by Dana...
The first CDISC SDTM/ADaM pilot project created a test submission of one study to the FDA using CDISC data and metadata standards, in order to test that these standards meet FDA requirements (described in a paper Greg Steffens presented at SUGI 2007). The second CDISC pilot project objectives are to...
How one chooses to implement CDISC will be based on current company standards and their robustness, the amount of control one has at each step of the data flow process, one's time vs. resource needs, and one's willingness to change. The author began by implementing CDISC between data collection and...
In the pharmaceutical environment, the CDISC Study Data Tabulation Model SDTM provides the framework for how clinical data should be submitted to the regulatory authority, such as the US Food and Drug Administration FDA. Specific metadata attributes, such as variable type, length, control terminology, and variable label, are established to...
Abakion is a Microsoft Gold Certified Partner that specializes in providing medium-sized companies with business management solutions based on Microsoft Dynamics NAV. An Abakion customer in the pharmaceutical industry was planning to build a new production plant for a medical product it wanted to sell in the United States. The...
Can we really have pre-emption without review?Buyer Beware has replace Do No Harm for Drug and Device Mfg. and the FDADana,You can't argue with good old fashioned common sense! Everything about preemption, from the way it was initiated without public debate in Congress to its purpose (protection of corporate profits...
The FDA is a scientific, regulatory and public health agency that works to ensure the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, U.S. food supply, and cosmetics. For over 10 years, GlobalNet Services, Inc. has supported the Food and Drug Administration with technology integration...
This essential mobile reference brings together in one place information on foodborne pathogenic microorganisms and natural toxins from the Food & Drug Administration, the Centers for Disease Control & Prevention, the USDA Food Safety Inspection Service, and the National Institutes of Health. Each section focuses mainly on either...
My feeling is that this will lead to illness and death that become matters for the criminal courts. Wyeth executives who skated in civil court, thanks to their friends in Washington, may find themselves behind bars one day. by Dana Blankenhorn
Clinical Research Information Exchange CRIX International is a not-for-profit collaborative consortium that includes government agencies, members of the biopharmaceutical industry, academic researchers, healthcare providers, and other stakeholders in the development of new drug therapies. Getting new drugs to market has always been a complex, costly and labor-intensive process. One of...
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