AFAIK, the situation is like this. As part of the 2007 update to the Food and Drug Administration Act added the authority for the FDA to require drug manufacturers to implement a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. The theory was that some drugs might have serious enough side effects or complicated treatment plans that the FDA should require drug manufactures to make sure patients weren't harmed needlessly by taking these drugs in a way not supported by safety trials (aka elements to assure safe use or ETASU).
As an example, they could restrict wholesalers to sell the drug only to physicians or patients who attended training seminars, or only allow use for certain purposes and time-limit quantities to prevent certain side effects, make sure medicine is stored correctly and destroyed when expired, and they could require patients to be monitored for certain specific serious side effects, not allow the drug to be administer to otherwise healthy people etc... Seemed like a good idea at the time....
The completely intendedresult of this is that Pharma companies have been crafting REMS to make it nearly impossible for generic manufacturers to obtain sufficient quantities of approved drugs for the required safety and equivalence trials. For example, a part of the ETASU might be that all patients must attend a company training seminar, or not allow the drug to be used on healthy people, but if you are doing a blind trial, that won't work.
To make the situation worse, even if the FDA didn't require REMS for a particular drug, the Pharma companies decided to "voluntarily" implement similar restrictions for their drugs on the wholesalers.
Wholesalers that don't comply with the Pharma's ETASUs would be violating both FDA rules and probably licensing restrictions and subject them to direct liability and thus will generally not sell product directly to these generic manufacturers. The only option remaining for generic manufacturers would be to purchase the product directly from the brand-name manufacturer. Under current law they are not required to sell drugs directly to their competitors and under strict interpretation of the FDA act, if a drug has a specific REMS, it is likely not technically legal.
Also even if the generic manufacturer decided to buy some of the drug on the "grey-market", they won't satisfy the requirements of the ANDA (abbreviated new drug application) which would require the same version available in the US market for demonstrating bio-equivalence.
FWIW, in 2012 there was an effort to amend the FDA act to allow the medical trials to bulk purchase of brand-name drugs at market prices and exempt REMS requirements, but it failed due to heavy lobbying...
I've been using a $5 mouse for over 10 years. Hardly something that will "break when you look at it". My keyboard cost I think $8 or something like that. It's lasted easily the same length of time. It's not like keyboards, mice, or even monitors routinely crap out and are replaced. Other than buying a new computer when was the last time you actually needed (not wanted) to replace your keyboard?
I don't know where "over here" is but in the US most banks won't cash a check for you unless you're a customer with an account. There is no fee (that I'm aware of) if you are an account holder, though.
As for processing payment, all methods of payment require processing that costs time and money. Credit card transactions, electronic payment of any kind and even cash payment requires processing. Some requires more time and money to process, obviously, but that's the cost of doing business. If a business is processing my payment "off-book" that's generally considered illegal and it is the business that has to deal with the repercussions, not the customer.
You are aware you aren't supposed to be paying taxes on services, right? You only pay taxes on merchandise/goods. If I pay a tree trimmer $1500 to top a tree in my yard, there are no goods/merchandise changing hands and a check is the right form of payment. I don't know any contractors using "e-invoicing" unless they work for a large corporate chain like roto rooter or something. Also, who cares if paying by check is "actively discouraged", it's a valid form of payment. If a contractor won't take a check they don't get my business. Simple rule.
I don't really care what the rest of the world is doing, if a check is the right option (you can stop payment on a check if the services weren't done correctly/satisfactorily and you have a record of payment that you don't have if you're paying cash) then it's the right option.
You would be wrong. Every job I've ever had (even the "non-office" blue collar jobs) people routinely printed. They still do if I go to any of those offices today. People are printing less at home, I believe, but certainly not in most corporate (and a lot of "blue collar") business environments. Others have mentioned plenty of examples that refute your claims. Hell, I printed no less than 10 documents in the last 2 days and I'm one of the people who uses our printers least in my office.
It's all about perspective but, as others have mentioned, the numbers don't corroborate your position in the slightest.
So, because NASA had two catastrophic failures SpaceX is cutting corners? Nice try. Seats don't need to be "Space rated". Many internal components don't need to be "space rated" as long as the external components protect them sufficiently by being "space rated". You're barking up the wrong tree.
As for the strut, do you really think there are no components that slip through the cracks at the "big boys"? Have you ever actually built anything? Infant mortality happens; it's a fact of life. That doesn't mean your supply chain is crap though it is ONE possibility. There are many many other possibilities though.
With respect to your engine failure example, if you really believe nine engines are "required" to do the job, you're clearly wrong as they have successfully delivered payloads with less. They have designed in redundancy, which is NOT a failure, no matter how you look at it. "Main engine" or not, if the mission was accomplished safely, it IS success.
Is SpaceX cutting corners? Sure. That's how they have had the success they have. Are they doing it in a controlled and well measured manner based upon years of engineering experience (in and out of space)? I believe so. Their track record is pretty strong so far. Consider that the Space Shuttle program had 135 missions over the course of 30 years. SpaceX has had 19 in how many years? 5? According to Wikipedia, if they keep on track, they'll have something like 60 missions before they hit 10 years of operation at a significantly reduced cost.
The only place where "facial recognition cameras" are common are places where you are requested to remove sunglasses, hats, etc anyway. The "let's enhance it and run it through the facial recognition software" seen on tv is utter crap. Until people start using higher resolution "security" cameras this will just be an expensive and stupid looking gimmick that will, as others have said, be easily overcome with a few software tweaks. Why are people worried about this?
Stop. Having the last word isn't important enough to look like you have no common sense or experience.
It's not like someone is going to get hired, have a year off immediately then change positions when they return. There will be accomplishments. Probably less than they would have had if they'd been actively working projects throughout, but that depends upon the specific job they do. The fact is, a resume is never going to show a gap in work and any apparent gap can easily be spoken to by anyone competent. If it can't be, they shouldn't be hired anyway.
And the overhead cost of managing both of these split entities would therefore rise, reducing the overall care they can give in either area. Any way you slice it, you're taking away money from women's health.
The argument to split Planned Parenthood into separate entities simply doesn't make any financial (or medical) sense. All it does is drive the overall cost of the healthcare up and, in the end, cost taxpayers more money.
I represent Boing Boing. I just received a Grand Jury Subpoena to Boing Boing dated June 12, 2015 (see attached).
The Subpoena requests subscriber records and user information related to an IP address. The IP address you cite is a TOR exit node hosted by Boing Boing (please see: http://tor-exit.boingboing.net...). As such, Boing Boing does not have any subscriber records, user information, or any records at all related to the use of that IP address at that time, and thus cannot produce any responsive records.
I would be happy to discuss this further with you if you have any questions."
Bold emphasis mine. The "at that time" portion is what is relevant here. What it has been used for at other times is irrelevant, if they're asking for a specific point or period of time. You can provide logs all day long about the activities during other times without it implying anything about the activities during the time the address was used as an exit node. It may still implicate YOU as someone who runs an exit node but there's currently nothing illegal about that.
That's where my concern would be. How many times will this happen before some jackass tries to make logs a requirement or makes it illegal to even host such a thing in the USA.
It hasn't caused "issues", it's caused paperwork. There's a difference. Every government employee I know has to do this for any kind of meals provided. Any gifts over $10, I think, also have to be accounted for in paperwork. It's a hassle but not an "issue".
For the record, you can't generally do that in "neighborhoods" either. No state I know of allows legal discharge of firearms within 200 feet of a home (less than 2 acres in size) except in defense of your life. You can't just hunt ducks from your porch if you have neighbors within several hundred yards of you no matter what kind of ammo you use.
I guess my point is if he really wants people to hear his music, he'll get it to as many people as possible. If he isn't touring anymore then it makes sense to keep the fidelity as high as possible. If he is still touring (I wouldn't know because I've never particularly liked most of his music) then it makes sense to get the audio to potential fans whatever way he can so that they will then get the "real" music at concerts.
By limiting his market he's seriously limiting himself because he will still have to realize that only a small portion of whatever market he goes for will actually enjoy his music.
His choice either way and I respect his insistence on quality but I think it's short sighted. Or others are right, he's just schilling for whatever player he prefers.
The problem with the whole argument, though, is that most consumers don't buy high end audio and it's fewer and fewer every year. Why bother with high bandwidth formats when people are listening on shitty Beats headphones pumped out by the millions every day?
I'm all for keeping fidelity in the music but the market doesn't agree. People want cheap disposable music to go along with their cheap disposable electronics. I agree with Young on the quality concern but he's going to lose out on at least one, probably several generations of fans by doing this. His music will die with the current generation of fans rather than being heard by successive new generations.
You are aware there's a difference between a miscarriage and a premature birth, right? Every translation I can find of Exodus 21:22 indicates "no serious injury" after the birth, implying a premature (but otherwise healthy) birth, rather than a miscarriage.
I know I'm nit-picking your post but your argument is seriously flawed for that particular portion.
As with most things, I suspect there's a certain amount of this you can "learn" and beyond that is where genetics comes into play. Even as a kid when my twin sister went to bed I was allowed to stay up and read for 3 more hours until my parents went to bed. For about 6 years I was sleeping 3 hours per night but it wasn't enough and I'd come home after work and crash for a 40 minute nap. My former room mate used to ask how I got so much stuff done but he slept 10-12 hours a night, which is the opposite end of extreme. I now sleep about 5 or 6 hours per night (when exercising regularly 6-7 hours when I'm not regularly exercising) and it's perfect for me. Any more than that and I actually feel more lethargic. I wouldn't say I'm a "short sleeper" in a genetic sense but I definitely enjoyed the productivity I had when I was trying to be one.
Unfortunately, when most people think of programmers, they think of the most common variety - web programmers. Unfortunately, what most don't realize is that web programmers in general are to programming what community colleges are to higher education (though there may be exceptions).
A stepping stone that proves you can be trained at a fraction of the cost? Your elitist bullshit about 4 year universities is just that... bullshit. Coding isn't magic. Yes truly good coders aren't common but just because someone learns a practical skill doesn't mean they're incapable of learning more "sophisticated" skills as well.
Bomber pilots and F-16 pilots don't have high resolution video of every strike. (They do with some missile strikes but not all) and usually get "visual confirmation" from other sources. Drone pilots have video the whole time and watch every second of it during strikes. Other drone pilots have to "confirm" but the shooter does see every bit of detail. Just because they aren't flying in the airspace themselves doesn't mean they don't get the impact of their actions.
As someone who grew up with an AF pilot father who flew both fighters and bombers and who now works with drone pilots regularly, I guarantee you drone pilots see far more of the damage they cause "close up" than bomber and most fighter pilots ever will.
Go sit a mission sometime. It's not what you think it is. Mostly it's monotonous, boring work. When there is an actual strike, it's a big deal. It's not like a video game at all, though. I promise you that.
I have sat these missions (not as a pilot) and I don't really understand the "stress" they are talking about. Other than the shift work, which can take a toll on family life, most of the folks I know doing these missions don't feel especially stressed about it.
I suspect this is a political push to change the AF standards of training required to do the job. The Army gives their UAS pilots ground training only. The AF, as far as I know, still requires full flight training. Big time and commitment difference. The AF also requires officers to do this while the Army allows enlisted, which means you get them younger, cheaper, and typically can hold onto them better because they don't have the same civilian opportunities by getting out.
So I can sell you sugar laced with arsenic? I can sell you rat labeled as chicken? Get real. You're very happy with the people telling your stores what they can and cannot sell you as long as it's some perceived benefit rather than some perceived slight.
Why in the world you would consider this a limit on your personal freedom I have no idea but we all have our crosses to bear. This may be one of yours, I guess. What exactly do you have a problem with in this decision? The lack of consensus in research or some concern you have over what the replacements will be (and their impacts) or just bitching for the sake of bitching?
Have you ever actually eaten rabbits, squirrels, lizards, snakes or frog legs? They taste nothing like chicken. Why do people always say this? Or people's pallets really so fucked up they can't distinguish between different types of meats?
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AFAIK, the situation is like this. As part of the 2007 update to the Food and Drug Administration Act added the authority for the FDA to require drug manufacturers to implement a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. The theory was that some drugs might have serious enough side effects or complicated treatment plans that the FDA should require drug manufactures to make sure patients weren't harmed needlessly by taking these drugs in a way not supported by safety trials (aka elements to assure safe use or ETASU).
As an example, they could restrict wholesalers to sell the drug only to physicians or patients who attended training seminars, or only allow use for certain purposes and time-limit quantities to prevent certain side effects, make sure medicine is stored correctly and destroyed when expired, and they could require patients to be monitored for certain specific serious side effects, not allow the drug to be administer to otherwise healthy people etc... Seemed like a good idea at the time....
The completely intended result of this is that Pharma companies have been crafting REMS to make it nearly impossible for generic manufacturers to obtain sufficient quantities of approved drugs for the required safety and equivalence trials. For example, a part of the ETASU might be that all patients must attend a company training seminar, or not allow the drug to be used on healthy people, but if you are doing a blind trial, that won't work.
To make the situation worse, even if the FDA didn't require REMS for a particular drug, the Pharma companies decided to "voluntarily" implement similar restrictions for their drugs on the wholesalers.
Wholesalers that don't comply with the Pharma's ETASUs would be violating both FDA rules and probably licensing restrictions and subject them to direct liability and thus will generally not sell product directly to these generic manufacturers. The only option remaining for generic manufacturers would be to purchase the product directly from the brand-name manufacturer. Under current law they are not required to sell drugs directly to their competitors and under strict interpretation of the FDA act, if a drug has a specific REMS, it is likely not technically legal.
Also even if the generic manufacturer decided to buy some of the drug on the "grey-market", they won't satisfy the requirements of the ANDA (abbreviated new drug application) which would require the same version available in the US market for demonstrating bio-equivalence.
FWIW, in 2012 there was an effort to amend the FDA act to allow the medical trials to bulk purchase of brand-name drugs at market prices and exempt REMS requirements, but it failed due to heavy lobbying...
Fixed that for you.
No, some genius will trademark the concept as "myCloud" or something like that and we'll all be paying royalties.
I've been using a $5 mouse for over 10 years. Hardly something that will "break when you look at it". My keyboard cost I think $8 or something like that. It's lasted easily the same length of time. It's not like keyboards, mice, or even monitors routinely crap out and are replaced. Other than buying a new computer when was the last time you actually needed (not wanted) to replace your keyboard?
I don't know where "over here" is but in the US most banks won't cash a check for you unless you're a customer with an account. There is no fee (that I'm aware of) if you are an account holder, though.
As for processing payment, all methods of payment require processing that costs time and money. Credit card transactions, electronic payment of any kind and even cash payment requires processing. Some requires more time and money to process, obviously, but that's the cost of doing business. If a business is processing my payment "off-book" that's generally considered illegal and it is the business that has to deal with the repercussions, not the customer.
You are aware you aren't supposed to be paying taxes on services, right? You only pay taxes on merchandise/goods. If I pay a tree trimmer $1500 to top a tree in my yard, there are no goods/merchandise changing hands and a check is the right form of payment. I don't know any contractors using "e-invoicing" unless they work for a large corporate chain like roto rooter or something. Also, who cares if paying by check is "actively discouraged", it's a valid form of payment. If a contractor won't take a check they don't get my business. Simple rule.
I don't really care what the rest of the world is doing, if a check is the right option (you can stop payment on a check if the services weren't done correctly/satisfactorily and you have a record of payment that you don't have if you're paying cash) then it's the right option.
You would be wrong. Every job I've ever had (even the "non-office" blue collar jobs) people routinely printed. They still do if I go to any of those offices today. People are printing less at home, I believe, but certainly not in most corporate (and a lot of "blue collar") business environments. Others have mentioned plenty of examples that refute your claims. Hell, I printed no less than 10 documents in the last 2 days and I'm one of the people who uses our printers least in my office.
It's all about perspective but, as others have mentioned, the numbers don't corroborate your position in the slightest.
So, because NASA had two catastrophic failures SpaceX is cutting corners? Nice try. Seats don't need to be "Space rated". Many internal components don't need to be "space rated" as long as the external components protect them sufficiently by being "space rated". You're barking up the wrong tree.
As for the strut, do you really think there are no components that slip through the cracks at the "big boys"? Have you ever actually built anything? Infant mortality happens; it's a fact of life. That doesn't mean your supply chain is crap though it is ONE possibility. There are many many other possibilities though.
With respect to your engine failure example, if you really believe nine engines are "required" to do the job, you're clearly wrong as they have successfully delivered payloads with less. They have designed in redundancy, which is NOT a failure, no matter how you look at it. "Main engine" or not, if the mission was accomplished safely, it IS success.
Is SpaceX cutting corners? Sure. That's how they have had the success they have. Are they doing it in a controlled and well measured manner based upon years of engineering experience (in and out of space)? I believe so. Their track record is pretty strong so far. Consider that the Space Shuttle program had 135 missions over the course of 30 years. SpaceX has had 19 in how many years? 5? According to Wikipedia, if they keep on track, they'll have something like 60 missions before they hit 10 years of operation at a significantly reduced cost.
The only place where "facial recognition cameras" are common are places where you are requested to remove sunglasses, hats, etc anyway. The "let's enhance it and run it through the facial recognition software" seen on tv is utter crap. Until people start using higher resolution "security" cameras this will just be an expensive and stupid looking gimmick that will, as others have said, be easily overcome with a few software tweaks. Why are people worried about this?
Stop. Having the last word isn't important enough to look like you have no common sense or experience.
It's not like someone is going to get hired, have a year off immediately then change positions when they return. There will be accomplishments. Probably less than they would have had if they'd been actively working projects throughout, but that depends upon the specific job they do. The fact is, a resume is never going to show a gap in work and any apparent gap can easily be spoken to by anyone competent. If it can't be, they shouldn't be hired anyway.
And the overhead cost of managing both of these split entities would therefore rise, reducing the overall care they can give in either area. Any way you slice it, you're taking away money from women's health.
The argument to split Planned Parenthood into separate entities simply doesn't make any financial (or medical) sense. All it does is drive the overall cost of the healthcare up and, in the end, cost taxpayers more money.
"Special Agent XXXXXX.
I represent Boing Boing. I just received a Grand Jury Subpoena to Boing Boing dated June 12, 2015 (see attached).
The Subpoena requests subscriber records and user information related to an IP address. The IP address you cite is a TOR exit node hosted by Boing Boing (please see: http://tor-exit.boingboing.net...). As such, Boing Boing does not have any subscriber records, user information, or any records at all related to the use of that IP address at that time, and thus cannot produce any responsive records.
I would be happy to discuss this further with you if you have any questions."
Bold emphasis mine. The "at that time" portion is what is relevant here. What it has been used for at other times is irrelevant, if they're asking for a specific point or period of time. You can provide logs all day long about the activities during other times without it implying anything about the activities during the time the address was used as an exit node. It may still implicate YOU as someone who runs an exit node but there's currently nothing illegal about that.
That's where my concern would be. How many times will this happen before some jackass tries to make logs a requirement or makes it illegal to even host such a thing in the USA.
It hasn't caused "issues", it's caused paperwork. There's a difference. Every government employee I know has to do this for any kind of meals provided. Any gifts over $10, I think, also have to be accounted for in paperwork. It's a hassle but not an "issue".
For the record, you can't generally do that in "neighborhoods" either. No state I know of allows legal discharge of firearms within 200 feet of a home (less than 2 acres in size) except in defense of your life. You can't just hunt ducks from your porch if you have neighbors within several hundred yards of you no matter what kind of ammo you use.
By definition it's not "OK for criminals to use deadly force to take your stuff". That makes it a crime.
I guess my point is if he really wants people to hear his music, he'll get it to as many people as possible. If he isn't touring anymore then it makes sense to keep the fidelity as high as possible. If he is still touring (I wouldn't know because I've never particularly liked most of his music) then it makes sense to get the audio to potential fans whatever way he can so that they will then get the "real" music at concerts.
By limiting his market he's seriously limiting himself because he will still have to realize that only a small portion of whatever market he goes for will actually enjoy his music.
His choice either way and I respect his insistence on quality but I think it's short sighted. Or others are right, he's just schilling for whatever player he prefers.
The problem with the whole argument, though, is that most consumers don't buy high end audio and it's fewer and fewer every year. Why bother with high bandwidth formats when people are listening on shitty Beats headphones pumped out by the millions every day?
I'm all for keeping fidelity in the music but the market doesn't agree. People want cheap disposable music to go along with their cheap disposable electronics. I agree with Young on the quality concern but he's going to lose out on at least one, probably several generations of fans by doing this. His music will die with the current generation of fans rather than being heard by successive new generations.
You are aware there's a difference between a miscarriage and a premature birth, right? Every translation I can find of Exodus 21:22 indicates "no serious injury" after the birth, implying a premature (but otherwise healthy) birth, rather than a miscarriage.
I know I'm nit-picking your post but your argument is seriously flawed for that particular portion.
As with most things, I suspect there's a certain amount of this you can "learn" and beyond that is where genetics comes into play. Even as a kid when my twin sister went to bed I was allowed to stay up and read for 3 more hours until my parents went to bed. For about 6 years I was sleeping 3 hours per night but it wasn't enough and I'd come home after work and crash for a 40 minute nap. My former room mate used to ask how I got so much stuff done but he slept 10-12 hours a night, which is the opposite end of extreme. I now sleep about 5 or 6 hours per night (when exercising regularly 6-7 hours when I'm not regularly exercising) and it's perfect for me. Any more than that and I actually feel more lethargic. I wouldn't say I'm a "short sleeper" in a genetic sense but I definitely enjoyed the productivity I had when I was trying to be one.
Unfortunately, when most people think of programmers, they think of the most common variety - web programmers. Unfortunately, what most don't realize is that web programmers in general are to programming what community colleges are to higher education (though there may be exceptions) .
A stepping stone that proves you can be trained at a fraction of the cost? Your elitist bullshit about 4 year universities is just that... bullshit. Coding isn't magic. Yes truly good coders aren't common but just because someone learns a practical skill doesn't mean they're incapable of learning more "sophisticated" skills as well.
Bomber pilots and F-16 pilots don't have high resolution video of every strike. (They do with some missile strikes but not all) and usually get "visual confirmation" from other sources. Drone pilots have video the whole time and watch every second of it during strikes. Other drone pilots have to "confirm" but the shooter does see every bit of detail. Just because they aren't flying in the airspace themselves doesn't mean they don't get the impact of their actions.
As someone who grew up with an AF pilot father who flew both fighters and bombers and who now works with drone pilots regularly, I guarantee you drone pilots see far more of the damage they cause "close up" than bomber and most fighter pilots ever will.
Go sit a mission sometime. It's not what you think it is. Mostly it's monotonous, boring work. When there is an actual strike, it's a big deal. It's not like a video game at all, though. I promise you that.
I have sat these missions (not as a pilot) and I don't really understand the "stress" they are talking about. Other than the shift work, which can take a toll on family life, most of the folks I know doing these missions don't feel especially stressed about it.
I suspect this is a political push to change the AF standards of training required to do the job. The Army gives their UAS pilots ground training only. The AF, as far as I know, still requires full flight training. Big time and commitment difference. The AF also requires officers to do this while the Army allows enlisted, which means you get them younger, cheaper, and typically can hold onto them better because they don't have the same civilian opportunities by getting out.
So I can sell you sugar laced with arsenic? I can sell you rat labeled as chicken? Get real. You're very happy with the people telling your stores what they can and cannot sell you as long as it's some perceived benefit rather than some perceived slight.
Why in the world you would consider this a limit on your personal freedom I have no idea but we all have our crosses to bear. This may be one of yours, I guess. What exactly do you have a problem with in this decision? The lack of consensus in research or some concern you have over what the replacements will be (and their impacts) or just bitching for the sake of bitching?
You are aware that most English speakers will pronounce ways, waze, and weighs identically, right?
Nice. Totally missed that in my post. Yet another Doh! moment.
Have you ever actually eaten rabbits, squirrels, lizards, snakes or frog legs? They taste nothing like chicken. Why do people always say this? Or people's pallets really so fucked up they can't distinguish between different types of meats?