I found this most interesting in the ruling:
"4. The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis."
Deeming Regulations have been released!!!!
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"4. The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis."
Same here. Its all going down hill just as I predicted four years ago.
I guess its nice to always have some hope, though. When I innitially applied for medical disability I was turned down without having a lawyer to support me. I had heard that you always get turned down on your first attempt. I then hired a medical disability attorney, and after 2 and a half years finally got a hearing before a judge. I didn't think it went well at all on my behalf at the hearing, but my attorney said confidently the hearing went exactly as he had planned. He told me most people who apply get frustrated over time and give up, and the "system" expects that. He said that we had stuck it out for the full count and he was optimistic that we would win. Sure enough, 2 - 3 weeks later my attorney wrote me thanking me for my "payment" and my business. He got informed before I did that we had won our case.
IMHO, the entire disability system is rigged between the judges and the lawyers. You don't stand a chance without an attorney representing you.
I feel the odds are against the vaping industry, with Big Pharma, Big tobacco, and the FDA all against us.
Two years - that's nothing. Took me 8 years. Unbelievably, with the 3rd hearing being with the toughest possible judge, no less. What was even more unbelievable, was that his favorable decision came only about 3 days after the hearing -- normally it was about 3-4 months for replies.
What is a joke is that the 1st and 2nd hearings are seemingly always(?) with THE EXACT SAME JUDGE! Just makes no sense.
OTOH, I tend to feel that if one really needs disability, then those that get frustrated and 'give up' may not really need it quite badly enough. IF they are ABLE to give up and just go to work, then I tend to think they can work. (That's not to say the honest ones wouldn't still have serious issues though.) For me, that was never going to be possible -- it was do or die, literally. But thankfully, my lawyer said he believed in the case so strongly, that he was going to stick it through to the end - even though after a 3rd hearing, it would fall under a new application and only be for SSI (thereby screwing him big time in the lawyer-fee department).
For me, if I were able to return to work tomorrow, I'd drop my disability the same day. It's been my goal to get back to that point which is why I'm stuck living where I am and constantly doing my physical therapy. But my other medical problems leave me wiped out, so it's slow progress at best.
But I have seen people go to such lengths to get it who are still able to work. They're the ones making it so difficult on those who really are disabled.
Vomit inducement #1 (just today).
Tobacco Stocks May Be Poised to Light Up
Vomit inducement #2 (just today).
This little-known tobacco stock is a big winner from e-cigarette bans
"Hate" isn't too strong a word in 2019, correct? I didn't think so. Thank you.
Tobacco Stocks May Be Poised to Light Up
Vomit inducement #2 (just today).
This little-known tobacco stock is a big winner from e-cigarette bans
"Hate" isn't too strong a word in 2019, correct? I didn't think so. Thank you.
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And when the kids start with smoking tobacco, or something else, the "epidemic " will have passed.
I really feel for you folks over the pond, vaping would appear to be condemned to the death of a thousand cuts. It's a nightmare planned and perpetrated by the corporates and government. We "only" have Brexitgate to cope with...
The mechanisms of all states continue to operate in the way they always have, the only change is that we can, occasionally, glimpse what really goes on and that information is now disseminated more widely than ever before.
I'm not a communist or a socialist ( he said quickly, looking over his shoulder) but here's a telling phrase from Marx in 1871-ish; "...blah blah... a blow straight from the shoulder at the present-day parliamentarian country, from America to Switzerland, from France to Britain, Norway and so forth--in these countries the real business of “state” is performed behind the scenes and is carried on by the departments, chancelleries, and General Staffs. parliament is given up to talk for the special purpose of fooling the "common people"."
The mechanisms of all states continue to operate in the way they always have, the only change is that we can, occasionally, glimpse what really goes on and that information is now disseminated more widely than ever before.
I'm not a communist or a socialist ( he said quickly, looking over his shoulder) but here's a telling phrase from Marx in 1871-ish; "...blah blah... a blow straight from the shoulder at the present-day parliamentarian country, from America to Switzerland, from France to Britain, Norway and so forth--in these countries the real business of “state” is performed behind the scenes and is carried on by the departments, chancelleries, and General Staffs. parliament is given up to talk for the special purpose of fooling the "common people"."
Bad, you might enjoy this tale of a fine ole Kaintucky lawyer
How a country lawyer pulled off biggest Social Security fraud ever, and why it could happen again
How a country lawyer pulled off biggest Social Security fraud ever, and why it could happen again
Same here. Its all going down hill just as I predicted four years ago.
I guess its nice to always have some hope, though. When I innitially applied for medical disability I was turned down without having a lawyer to support me. I had heard that you always get turned down on your first attempt. I then hired a medical disability attorney, and after 2 and a half years finally got a hearing before a judge. I didn't think it went well at all on my behalf at the hearing, but my attorney said confidently the hearing went exactly as he had planned. He told me most people who apply get frustrated over time and give up, and the "system" expects that. He said that we had stuck it out for the full count and he was optimistic that we would win. Sure enough, 2 - 3 weeks later my attorney wrote me thanking me for my "payment" and my business. He got informed before I did that we had won our case.
IMHO, the entire disability system is rigged between the judges and the lawyers. You don't stand a chance without an attorney representing you.
I feel the odds are against the vaping industry, with Big Pharma, Big Tobacco, and the FDA all against us.
It happens here in the U.S. as well. Our public education system is based upon the Prussian kindergarten which raised children to be soldiers/workers/consumers. We either realize this but don't speak up on it, or we don't realize it because "man that Kool Aid is yummy". We also have Child Protective Services which does grant the STATE wards by taking children from parents to raise. I'm not saying that is always a "bad" thing, but it is a thing that exists.
My point being the U.S. is not excluded in regards of the atrocities mentioned. In fact we're likely as bad, or worse than some other places. But oh we got representative democracy to rule our Republic, wherein the representatives do not represent the People but Capital and other Special Interests. Rotten to the core, imho all that remains is Igne Natura Renovatur Integra. Though most do not care to hear that.
I apologize to you @Katya. My posting here is not intended, nor directed as a personal attack. I am instead attacking the ideas you refereed to you in your post. My apology is extended in case there is any misunderstanding, though I doubt someone with your mental acumen will misunderstand.
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This is how I see 'most everything nowadays.
Couldn't disagree with you about the role of Capital in the USA. I'm a bit in the dark about the reasons for your disapproval of our education system though. I think they should be better funded and a higher national priority but I suspect that isn't where your disapproval comes from. I'm interested because my GD is a teacher.
Not really pertinent to the thread but we have to keep ourselves busy while we wait for the next FDA bombshell.
You're asking a valid question for equally valid rationale. Thank you for that.
My disappointment / disapproval comes from recalling what was once called a liberal arts education. This involved the trivium and quadrivium. This education taught one to think, observe, process information and data freely for themselves.
I would be more open to seeing that kind of education funded and presented in public education. The system which is being used is little more than forced indoctrination and does not care to let one think freely, just recite rote facts regurgitated by instructors. It makes people Human Resources.
Granted I do not see that as completely negative. Some do need exactly that. Then, what of those who might be dreamers that go on to explore new worlds off our planet? They'll be educated in the same "boxed in" fashion and not be able to think for themselves when it might be all that could save a life, or create new possibilities for humanity.
I think both systems have merits and counter-merits. Yet all that is given to the public choice is one system and it is made mandatory.
Note of fairness: I'll not father children. That does not I think exclude me from seeing both good and bad regarding education. I understand some might think it does. I understand the reasoning they would use to think that. If I've no "skin in the game" why would it concern me? Well, frankly because I live in this society we all choose to share as well. Do we not all have some kind of "skin" or otherwise in the "game"?
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Wonderful. The part there I don't get is the guy was choosing to represent those with disabilities to fast track through. He got caught and the administrative judge got caught. But if a cursory review showed that even some, never mind most of applications, were for valid disabilities, why cut them all off pending an updated review? If cases are found which were wrong and shoved through for approval, the penalty to the supposedly disabled person is a federal fraud charge, not just suspending payments. And for those that were legit, why withhold payments while that was in process?
It's a wonderful system we've spun together to trap ourselves in.
This sorta far afield of the thread's topic, but what liberal arts education are you referring to? If you're invoking this in primary school, specifically kindergarten through 8th grade, that's where a child needs to learn the basics of things like reading, writing, and math to he able to ever benefit from a liberal arts education down the road. It's kinda tough to expect someone to grow up able to debate over Kant in Philosophy or even Vonnegut in English Literature in high school if they're functionally illiterate.
The path to graduate education in the US is not quite as rigid as in other western nations. While there are college entry exams they are only one part of an application, and if anything a declining part in the holistic evaluation of a college application. Plenty of other nations where your score determines where, or even if, you'll have an opportunity to pursue graduate education (including liberal arts) regardless of other factors such as grades, extracurricular activities and achievements, and even the context your education was achieved under.
You cannot observe, think, and evaluate the world around you without basic skills required across all areas of learning. While educational standards have become more rigid in the US, it's been done with the intent if assuring all children are properly equipped for their grade. There is no doubt this leads to less inventive class programs and overreliance on testing, but that continues to be refined and adjusted, rather than leaving a free for all in determining what the class plan should be in second grade.
There are very talented students who are placed in different programs suitable to their abilities. Not all students will function well in those environments. There are programs for students who are unable to maintain pace and are given specialized classes to help them master the skills needed at a rate they can obtain.
A well rounded liberal arts education requires a very solid foundation to build upon. Some schools are better than others. When you include private education in the US in the picture there's a wide range of teaching methods available. But that really begins to kick into gear by middle school and then high school, not kindergarten. And with the absence of any standards you really leave the door open to taxpayer funded public schools incapable of demonstrating their students are being taught, period. Granted there needs to be a balance and there needs to be room for individual discovery, but I'd rather know my tax dollars are assuring at least a floor to what must be taught. I have no issue with exceeding that at all.
My recollection of schools in England in the 50's and 60's is that there was a multitrack system. One type of school trained the children of the working class for working class jobs. One trained children of the middle class to go to university and on to middle class jobs. Etc. The top tier was a group of elite private schools, strangely named Public Schools. They trained the children of the elite to run the country.
In the interests of breaking up the old class system they eventually merged them all together, except for the Public Schools which were private and wildly expensive. Similar to bussing in America, except that addressed race rather than class.
Now in the USA funding has been tied to "achievement". You get funds dependent on how many kids you can push through the standardized tests. So all the goofy stuff like art and music and sport and so forth gets shorted. And ideologs try manipulate the curriculum to reinforce their ideologies and religions.
But my school had really demanding exams and passing really mattered. I don't think that led to any narrowing of the learning experience. Maybe because it wasn't tied to funding.
We had discipline in the classroom. There were no cellphones, but if someone had done something like pulling out a cell phone in class it would have been a major scandal. Whackings and meetings with the Headmaster and all sorts of trouble. Outside the classroom it was a free for all. Smoking, fistfights, vandalism and all the rest.
I read about a country, either Finland or Norway I think, where teaching is an elite highly paid profession on a par with university professors. Schools fight to hire the top graduates from the universities. They had the results you would expect. The smartest kids were educated to the max, all the kids came out in world beating shape.
I really have no idea how the USA could do it better. I suspect as long as it's an ideological football nothing much good will happen. Bumper sticker solutions like standardized tests, let the free market run it, get rid of the unions. In reality it's going to take grown-ups to fix this one.
You are correct, most benefits will be restored as time goes on. There are a large number of KY attorneys who are working to rectify the wrong.
I was very lucky: my application was accepted right away (well, after six or so months, but it always takes that long). No lawyer necessary.
One thing they could do to improve education in the U.S. is to get the federal government OUT of it. We ranked much higher before the peanut farmer established the Federal Department of Education. Now, we get federal programs forced on public schools such as Outcome-based education, School-to-Work, and I forget the name of the latest POS forced indoctrination program. Turn public education back to the states, communities, teachers and parents.
What I am saying is that Liberal Arts in the manner of Classical Antiquity used to be the standard. The teaching of it began and it was the baseline, floor, foundation on which higher education was built. If children seemed more keen to practicing trades they would be placed to apprentice in those trades as suited. There was actual involvement by communities, villages, towns and so on.
Then, the Federal government became involved and it became as you say here, tied to achievement. Inner cities and rural areas cannot afford to pay wages of "rock star" level teachers for public funded schools. Private schools are not afforded by those who do require some form of subsidized education for children.
Ergo, the liberal arts got binned in favor of simply given children a smattering of facts without any knowledge, wisdom or capacity to use these facts to any worth while purpose. All that was cared about was getting children to obey authority, cite useless facts to pass "standard" tests.
This pattern given time creates a mindless mass that now happily allows others to think for them.
"Well the FDA says vaping is bad so it must be." (Applies here in the U.S.A)
Do I need to expound upon this one?
"I saw on the news it's the evil Muslims what do suicide bombings and our government wants to protect us from them. I know Mike next door reads the Quran. Mike then must be a suicidal bombing Muslim, I'll report him to the government."
I have seen manuals in use by the C.I.A, an agency of our government, that instruct on how to create bombs which can effectively be used in suicide strikes. I've read histories of The Inquisitions, where Christians were heard to have said "burn the whole village down because the one witch here cannot be found, God will sort his own." My point is it isn't all Muslims that do evil, nor do all those doing evil use suicide bombs.
"The preacher in my church says God hates homosexual people. He says it says in the Bible. I'm not sure how to read the Bible or where to find that, or how to think about the Bible. I'll take my preacher's word for it because he knows all about the Bible."
The one admonishment that nears being anywhere close to condemning homosexuality, is instead condemning pedophilia. There's a verse stating roughly "men shall not lay with boys". There is no real condemning of homosexuality in the Christian Bible. Yes, I've looked. My point being authorities might not know, or might knowingly lie to you. And it isn't only religious leaders that I count as authorities.
And further clarity. I am not attacking any one religion, philosophy here. I am also not being abusive of homosexual people. That would be rather hypocritical and immature of me, a bisexual man to do. I'm also not attacking straight people, white, black, red, yellow. I am though attacking the ideology what creates labels amongst us and hate. Sometimes that comes from supposed authority.
Further then, our hate as the collective society fuels this fouled up education doled out. How so? Well, why should the wealthy (Capital) desire any better than mindless "employees" to do the bidding? Why would Capital want for people to freely understand technology exists now to create your own mini-factories to create goods? Capital does not want competition from every Joe on the street able to spend $300 - $400 to set up a 3D printer that can make clock gears from plastic for example.
So give us labels, divide us and keep us in the dark. Don't let us have the capacity to think, to create, to do. Yes, I understand there are exceptional children who rise further. Someday I might pause and think of myself as one. Until then though, I look at what is and have to see it as part of the rotten core.
Well to me we're all one human race. I might rather insult a platypus by calling some human being one, to me that would be me actually being racist & offensive to platypuses.
I've never bought the idea some are inferior due to [Insert Whatever Here]. Instead I recall what we put in our Deceleration of Independence, we are all equal. I might go a bit further and say I'm equal to a flea, ant, horse, pig, cat, dog, any other creature on Earth. Others might not share this notion of equality, in fact I know they don't. I won't press for it either. My views are mine, not everyone needs to hold them or agree. I do see what was being attempted though in breaking up class. I think now in America, we are nearing a class thing. I don't want to say revolution because revolutions bring us right back around to the same thing again, they revolve. I'd like to see us evolve instead, go farther, climb higher on the ladder of our aspirations. Yet I understand not everyone desires that and again I won't press. I think it is an idea who time has come but only time will tell.
My apologies if I've missed words here, or there, have grammar errors. Been awake now since 3 AM EST this morning. May get to bed about 1 AM here. I'm also having lolly fun with some kidney issue. My mind is not quite to par.
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