“FDA Promises Final Mobile App Guidance by October 2013 & Sets Limits on What Types of Apps It Will Regulate”

Monday, March 25, 2013-Pharma Marketing Blog-Pharma Guy

“In testimony at the March 21, 2013 House Subcommittee on Oversight and Investigations regarding Health Information Technologies: Administration Perspectives on Innovation and Regulation, Christy Foreman, Director of FDA’s Office of Device Evaluation, Center for Devices and Radiological Health, “promised” that FINAL guidance regarding the regulation of Mobile Medical apps (MMAs) will be released by the end of the current fiscal year; i.e., before October 2013 (read her words here).

There’s been quite a lot of fear mongering regarding the types of health apps that FDA will seek to regulate. PhRMA, for example, agreed with an editorial that suggested the FDA will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices (see “Mobile Regulatory Fears: PhRMA Raises an Alarm”). Foreman specifically excluded such apps in her answers to questions from Rep. Henry Waxman (D-CA):


“ACTers Software is a web-based case management software program that combines the features of a traditional case management system, electronic medical record, and outcomes monitoring all in one.”

“The History of our Sewage Disposal System”

“And even though V. I. Lenin, at the end of 1917, in order to
establish “strictly revolutionary order,” demanded “merciless
suppression of attempts at anarchy on the part of drunkards,
hooligans, counterrevolutionaries, and other persons” 2 — in other
words, foresaw that drunkards and hooligans represented the
principal danger to the October Revolution, with counterrevolu-
tionaries somewhere back in third place — he nonetheless put the
problem more broadly. In his essay “How to Organize the Com-
petition” (January 7 and 10, 1918), V. I. Lenin proclaimed the
common, united purpose of “purging the Russian land of all
kinds of harmful insects.” 3 And under the term insects he in-
cluded not only all class enemies but also “workers malingering
at their work” — for example, the typesetters of the Petrograd
Party printing shops. (That is what time does. It is difficult for
us nowadays to understand how workers who had just become
dictators were immediately inclined to malinger at work they
were doing for themselves.) “
The Gulag Archipelago

Dung beatles:more potential counterrevolutionaries

counterrevolutionary astronomer dung beatles in need of purging:


A bombardier beatle in need of smashing! Don’t let the red carapace fool you comrade!

“”This person suffering from hereditary defects costs the community 60,000 Reichsmark during his lifetime. Fellow German, that is your money, too.”-Wiki Media

“The German census of May 1939 indicates that 54 percent of Germans considered themselves Protestant, (including non-denominational Christians) and 40 percent considered themselves Catholic, with only 3.5 percent claiming to be neo-pagan “believers in God,” and 1.5 percent nonbelievers. This census came more than six years into the Hitler era”

“There is no escape, we pay for the violence of our ancestors”-Frank Herbert

filed under-avoidance of institutional liability

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