I am unaware of the specific cases you may be referring to, but whether a component is already tested or not, is only a part of that process. Companies have to prove that a) they make that component exactly as described in the filing, and b) that the result is that particular component. Nothing more, nothing less.
For example, if I make aspirin, I have to make a filing with the FDA, with all the details of what I am going to make, en with an exact description of the process I am going to use, even going so far as dimensions of vessels, mixers, etc. the company I work for makes a specific drug that used to require being made in a 1000 liter reactor. We had to refile for approval for our 2000 liter bioreactors. And this was not simply a matter of rubber stamping. It started with a new audit, investigation, approval process etc.
Even moving a production line to a new plant next door means starting over. When we built our new plant right next to the old one, it took years to get approval. That is just how the regulatory process works. Not just the FDA in the US, but also the FAGG in Europe for example.
From breaking ground for a new plant to getting approval to distribute is a process that can easily take between 5 and 7 years. And this is because there is the need for guarantees on the process and the product, and not just 'best effort' or 'good enough'
Also, one of the additional requirements is that a company needs to prove they have all the organizational processes in place to comply with how a pharma company needs to be run. There is a thing called pharamcopeia which describes all the testing you need to have in place, how to deal with test results, how results need to be escalated, etc. You need to have working processes for dealing with exceptions and deviations, batch review and release, etc.
The product we make can be made by a PHd student with access to a simple million dollar lab. But to make a product that is suitable for intravenous use in compliance with ALL standards, takes a site with about 400 employees, half a billion dollar in initial investment, and ten to 30 million in annual upkeep costs.
Just saying: getting approval for actual use is orders of magnitude more difficult and time consuming than just making the component in a lab.
"Imagine you have the world's most bloated operating system, supporting legacy APIs so old and iteratively patched and fixed that your code base has become pretty wretched."
You are conflating the Windows 'Distro' with the Windows OS kernel. The Windows kernel is pretty good and well designed.
As opposed to say the US, which is basically spending China's money? China has been buying enormous amounts of US bonds. By spending money they don't have, the US has neatly placed their testicles in China's hands.
There is a difference between asking the population for non binding input on a specific issue, and a binding referendum on something that is essentially a large constitutional change without even saying in advance what exactly you are voting for.
The problem with the brexit referendum was that they only required a simple majority while a normal constitutional change would require a 2/3. And there was no definition of what the desired output was. It was essentially a vote to exit the EU without any plan, and without any agreement on which conditions to negotiate for. It was a victory for populism and a loss for informed democracy.
You are correct. I have discussed this with my American friends several times. I live in a gun free (mostly) country and when I visit the US, my friends usually take me shooting, bring enough guns to outfit the army of a small country and they keep putting different things in my hands, one after another. I mean on a personal level I love shooting, but that doesn't mean I am pro or contra carry.
My American friends (even the 2A folks) agree with me that in a un free country like mine, restricting guns can work because you don't get an arms race between good and bad people (and the cops). Having a gun as a criminal, in my country, makes anything you do infinitely more serious. Even burglars typically don't have guns. Not introducing guns makes for an overall safer society if we simply go by the numbers.
But in a country like the US, that simply is no longer an option. That ship has sailed. And without wanting to go into a political / moral discussion about the right to bear arms: restricting guns in the US, like in my country, simply doesn't work. And that is not even taking into account that there are vast rural places in the US where you need guns for safety. Not only because cops can be hours away, but also because you can regularly encounter moose, coyote and bears, depending on where you live.
There is absolutely nothing useful about a bump stock ban. But after the Las Vegas shooting, a blood sacrifice needed to be made to appease the masses, and bump stocks became the sacrificial lamb.
You are correct to say that there was meant to be a balance. However, there was an inherent safety factor, in that 1 nutcase or person with bad intentions could not mow down a room full of people with off the shelf available guns. If you wanted to present a show of force, you needed enough people to agree with you to actually do that kind of damage.
Interpretation and laws need to change with the context in which they exist. Because otherwise, the spirit in which they were written is no longer observed. The 2nd amendment was written in the day of muzzle loaders, not full auto machine guns. 1 person being able to quickly murder 100 people was not the intention of the 2nd amendment.
Illegal immigrants in the US. Separated from their children, who are put in camps, and sometimes kennels. I've seen a significant number of people saying that is the right thing to do and if they didn't want that treatment, they should not have come there in the first place. I've seen many people with zero empathy over this issue.
I'm not even saying you have to say the actions are wrong. But you can express empathy over measures you think that need to be taken. But a total lack of empathy is a very dangerous thing. Because without empathy, someone is bound to suggest the next step towards 'the final solution'
It may come as a surprise, but even right wingers here are not supporting the separation of children from their parent if they cross the border illegally. And I have seen many Americans imply that it's only right because hey, if they didn't want their children taken, they should have stayed at home. I've seen very little empathy on the conservative side.
While you are correct on your designation of the show, it is still a fact that they understand the high end car segment. I cannot afford any of what they show, but I can see that if they say car X is a great car to drive, then X may not be the greatest car ever built, but it will be a damn fine car if you care about driving quality / enjoyment and don't have to care about things like cost, road taxes or fuel efficiency.
Btw I actually got to drive a Tesla sport and a more recent Tesla. Both cars drove nice but I have to say the recent one had a lot of touch screen stuff and I didn't like that.
Even in nerdy crowds, nerds and geeks are still people, with a lot of variance in personality.
If you notice something that could be a problem, it is generally a lot less problematic to simply ask 'did you mean this or that' and take it from there. By immediately going into a lengthy monologue, explaining that the other person made a mistake but it's ok because you know why she made a mistake and myabe this could create other problems and...' That is generally perceived by other people as condescending.
There are reasons why you may still want to use clearcase. I've worked in companies developing medical software, and for regulatory purposes, clearcase has a lot of certifications that are important when the FDA comes visiting and demands audit trails etc.
Companies need to prove things like audit trail correctness and many other things. And with something like clearcase, you get the relevant documentation out of the box. If you have to prove all those things for your git repository, that is a fuckton of work. And you'd have to re-do wit with every upgrade, and even do an assessment of every single patch you install. I don't want to disparage git. It's a good tool. But in regulated environments, there are many more things to consider.
I work in pharma, and have written relatively simple applications that needed to be validated for GMP use (official data use for the manufacturing of drugs) and the amount of paperwork and process involved in validating even small applications is daunting. And with every change, you need to do an assessment, follow formal GMP compliant change control, and re-do a lot of testing and paperwork.
And in the face of that, it may very well be worthwhile to buy expensive clearcase licenses, instead of using git.
You sound like you think it is great you're being worked to death and that you have to sacrifice your family life on the altar of your career. It's true, you may earn more, depending on where you live. But by the time you are done paying for good health insurance, a good dental plan, and subtract all the co-pay you still have to pay... and then deduct cost of living... you probably have left the same as us. Minus the family life of course.
France kept the English from sending reinforcements and helped you become an independent nation. You were perfectly happy to let the Germans steamroll over the rest of Europe until pearl harbor.
In the end, the US only cares about the US. Why do you expect the EU to be 'loyal'? Everything the US did, it did to get more in return.
It helps if you talk with them about getting a paycheck, explaining what a mortgage is, explaining what income tax is, etc. We have always explained adult life in terms the kids can understand. And they're able to use a smartphone and tablet in a responsible manner. They also get a small allowance since first grade, just to make them get some experience with balancing 'wants' with the reality of limited funds.
That is good for you. Unfortunately, the bank in question has experienced 22% of people defaulting on their payments because they did not get the anticipated profits and don't actually have any money.
Equally stupid, but I would guess that not that many people are stupid enough to do that, whereas too many people bought bitcoin at 20K, sure it would 40K by the end of the week because John McAfee said so.
Here's the thing: In Belgium we have a do not call list. It works, too. And I think I receive only about 1 spam call on my cell phone per year. My friends in the US tell me that this is much more a problem in the USA.
I don't know how things are in your part of the world, but in europe there is a sginificant percentage of millenials who cannot afford a house because they 'need' a fully furnished modern house with a luxurious bathroom and quality kitchen. And of course they also 'need' a summer holiday and at least a skiing weekend trip. There are a good number of millenials who have grown up with a level of luxury that they immediately seek to step into when moving out.
This is something I still don't understand. It is up to the criminal court to decide whether the officers dis something wrong or not. If they didn't, then it's strange that the next of kin can essentially get a do-over with lower standards of guilt. In Europe, at least in most countries I am aware of, only the state can bring homicide cases to the court. When that is done, it is done.
The US system allows someone to for example win a self defense case, only for the person who defended himself still to be fucked over in criminal court.
A baby right before delivery is as alive as right after delivery, and equally capable of surviving on its own. I am not arguing against abortion, just pointing out that the 'alive' argument can be taken to the ridiculous. If the baby is considered alive right after delivery, it's also alive right before delivery. And a day before, and 2 days before, etc.
At some point, you can argue that the foetus is not alive, I suppose, but obivously the question is more complex than argument that just because the bun is still in the oven it cannot possibly be alive. So in many cases, abortion can literally mean ending a life, whereas in other, much earlier stages, it doesn't mean ending a life.
No. It goes to show how it's still the best for 'some' projects. For other tasks, C# or Java or something else would be equally fast but many times easier to develop, easier to test and easier to maintain. It all depends on the context of the project. there is no single 'teh best' (typo intentional) programming language.
Slashdot Mirror
I work in big pharma.
I am unaware of the specific cases you may be referring to, but whether a component is already tested or not, is only a part of that process. Companies have to prove that a) they make that component exactly as described in the filing, and b) that the result is that particular component. Nothing more, nothing less.
For example, if I make aspirin, I have to make a filing with the FDA, with all the details of what I am going to make, en with an exact description of the process I am going to use, even going so far as dimensions of vessels, mixers, etc. the company I work for makes a specific drug that used to require being made in a 1000 liter reactor. We had to refile for approval for our 2000 liter bioreactors. And this was not simply a matter of rubber stamping. It started with a new audit, investigation, approval process etc.
Even moving a production line to a new plant next door means starting over. When we built our new plant right next to the old one, it took years to get approval. That is just how the regulatory process works. Not just the FDA in the US, but also the FAGG in Europe for example.
From breaking ground for a new plant to getting approval to distribute is a process that can easily take between 5 and 7 years. And this is because there is the need for guarantees on the process and the product, and not just 'best effort' or 'good enough'
Also, one of the additional requirements is that a company needs to prove they have all the organizational processes in place to comply with how a pharma company needs to be run. There is a thing called pharamcopeia which describes all the testing you need to have in place, how to deal with test results, how results need to be escalated, etc. You need to have working processes for dealing with exceptions and deviations, batch review and release, etc.
The product we make can be made by a PHd student with access to a simple million dollar lab. But to make a product that is suitable for intravenous use in compliance with ALL standards, takes a site with about 400 employees, half a billion dollar in initial investment, and ten to 30 million in annual upkeep costs.
Just saying: getting approval for actual use is orders of magnitude more difficult and time consuming than just making the component in a lab.
"Imagine you have the world's most bloated operating system, supporting legacy APIs so old and iteratively patched and fixed that your code base has become pretty wretched."
You are conflating the Windows 'Distro' with the Windows OS kernel. The Windows kernel is pretty good and well designed.
As opposed to say the US, which is basically spending China's money?
China has been buying enormous amounts of US bonds. By spending money they don't have, the US has neatly placed their testicles in China's hands.
There is a difference between asking the population for non binding input on a specific issue, and a binding referendum on something that is essentially a large constitutional change without even saying in advance what exactly you are voting for.
The problem with the brexit referendum was that they only required a simple majority while a normal constitutional change would require a 2/3. And there was no definition of what the desired output was. It was essentially a vote to exit the EU without any plan, and without any agreement on which conditions to negotiate for. It was a victory for populism and a loss for informed democracy.
Yet the Windows API has been stable for a long time. And even device driver frameworks such as KMDF and UMDF have been stable for a long time.
You are correct. I have discussed this with my American friends several times. I live in a gun free (mostly) country and when I visit the US, my friends usually take me shooting, bring enough guns to outfit the army of a small country and they keep putting different things in my hands, one after another. I mean on a personal level I love shooting, but that doesn't mean I am pro or contra carry.
My American friends (even the 2A folks) agree with me that in a un free country like mine, restricting guns can work because you don't get an arms race between good and bad people (and the cops). Having a gun as a criminal, in my country, makes anything you do infinitely more serious. Even burglars typically don't have guns. Not introducing guns makes for an overall safer society if we simply go by the numbers.
But in a country like the US, that simply is no longer an option. That ship has sailed. And without wanting to go into a political / moral discussion about the right to bear arms: restricting guns in the US, like in my country, simply doesn't work. And that is not even taking into account that there are vast rural places in the US where you need guns for safety. Not only because cops can be hours away, but also because you can regularly encounter moose, coyote and bears, depending on where you live.
There is absolutely nothing useful about a bump stock ban. But after the Las Vegas shooting, a blood sacrifice needed to be made to appease the masses, and bump stocks became the sacrificial lamb.
You are correct to say that there was meant to be a balance. However, there was an inherent safety factor, in that 1 nutcase or person with bad intentions could not mow down a room full of people with off the shelf available guns. If you wanted to present a show of force, you needed enough people to agree with you to actually do that kind of damage.
Interpretation and laws need to change with the context in which they exist. Because otherwise, the spirit in which they were written is no longer observed. The 2nd amendment was written in the day of muzzle loaders, not full auto machine guns. 1 person being able to quickly murder 100 people was not the intention of the 2nd amendment.
Just a wild guess: you think that the US style federal prison, with gang rape, extortion, and senseless violence is just what the doctor ordered?
Illegal immigrants in the US.
Separated from their children, who are put in camps, and sometimes kennels.
I've seen a significant number of people saying that is the right thing to do and if they didn't want that treatment, they should not have come there in the first place. I've seen many people with zero empathy over this issue.
I'm not even saying you have to say the actions are wrong. But you can express empathy over measures you think that need to be taken. But a total lack of empathy is a very dangerous thing. Because without empathy, someone is bound to suggest the next step towards 'the final solution'
It may come as a surprise, but even right wingers here are not supporting the separation of children from their parent if they cross the border illegally. And I have seen many Americans imply that it's only right because hey, if they didn't want their children taken, they should have stayed at home. I've seen very little empathy on the conservative side.
While you are correct on your designation of the show, it is still a fact that they understand the high end car segment. I cannot afford any of what they show, but I can see that if they say car X is a great car to drive, then X may not be the greatest car ever built, but it will be a damn fine car if you care about driving quality / enjoyment and don't have to care about things like cost, road taxes or fuel efficiency.
Btw I actually got to drive a Tesla sport and a more recent Tesla. Both cars drove nice but I have to say the recent one had a lot of touch screen stuff and I didn't like that.
You do realize the clock is implemented in hardware and unrelated to whatever OS happens to be installed? But yeah. 'Boo Windoze'
Even in nerdy crowds, nerds and geeks are still people, with a lot of variance in personality.
If you notice something that could be a problem, it is generally a lot less problematic to simply ask 'did you mean this or that' and take it from there. By immediately going into a lengthy monologue, explaining that the other person made a mistake but it's ok because you know why she made a mistake and myabe this could create other problems and...' That is generally perceived by other people as condescending.
There are reasons why you may still want to use clearcase. I've worked in companies developing medical software, and for regulatory purposes, clearcase has a lot of certifications that are important when the FDA comes visiting and demands audit trails etc.
Companies need to prove things like audit trail correctness and many other things. And with something like clearcase, you get the relevant documentation out of the box. If you have to prove all those things for your git repository, that is a fuckton of work. And you'd have to re-do wit with every upgrade, and even do an assessment of every single patch you install. I don't want to disparage git. It's a good tool. But in regulated environments, there are many more things to consider.
I work in pharma, and have written relatively simple applications that needed to be validated for GMP use (official data use for the manufacturing of drugs) and the amount of paperwork and process involved in validating even small applications is daunting. And with every change, you need to do an assessment, follow formal GMP compliant change control, and re-do a lot of testing and paperwork.
And in the face of that, it may very well be worthwhile to buy expensive clearcase licenses, instead of using git.
You sound like you think it is great you're being worked to death and that you have to sacrifice your family life on the altar of your career.
It's true, you may earn more, depending on where you live. But by the time you are done paying for good health insurance, a good dental plan, and subtract all the co-pay you still have to pay... and then deduct cost of living... you probably have left the same as us. Minus the family life of course.
France kept the English from sending reinforcements and helped you become an independent nation.
You were perfectly happy to let the Germans steamroll over the rest of Europe until pearl harbor.
In the end, the US only cares about the US. Why do you expect the EU to be 'loyal'? Everything the US did, it did to get more in return.
It helps if you talk with them about getting a paycheck, explaining what a mortgage is, explaining what income tax is, etc.
We have always explained adult life in terms the kids can understand. And they're able to use a smartphone and tablet in a responsible manner.
They also get a small allowance since first grade, just to make them get some experience with balancing 'wants' with the reality of limited funds.
That is good for you. Unfortunately, the bank in question has experienced 22% of people defaulting on their payments because they did not get the anticipated profits and don't actually have any money.
Equally stupid, but I would guess that not that many people are stupid enough to do that, whereas too many people bought bitcoin at 20K, sure it would 40K by the end of the week because John McAfee said so.
Here's the thing: In Belgium we have a do not call list. It works, too.
And I think I receive only about 1 spam call on my cell phone per year.
My friends in the US tell me that this is much more a problem in the USA.
I don't know how things are in your part of the world, but in europe there is a sginificant percentage of millenials who cannot afford a house because they 'need' a fully furnished modern house with a luxurious bathroom and quality kitchen. And of course they also 'need' a summer holiday and at least a skiing weekend trip. There are a good number of millenials who have grown up with a level of luxury that they immediately seek to step into when moving out.
This is something I still don't understand. It is up to the criminal court to decide whether the officers dis something wrong or not. If they didn't, then it's strange that the next of kin can essentially get a do-over with lower standards of guilt. In Europe, at least in most countries I am aware of, only the state can bring homicide cases to the court. When that is done, it is done.
The US system allows someone to for example win a self defense case, only for the person who defended himself still to be fucked over in criminal court.
A baby right before delivery is as alive as right after delivery, and equally capable of surviving on its own. I am not arguing against abortion, just pointing out that the 'alive' argument can be taken to the ridiculous. If the baby is considered alive right after delivery, it's also alive right before delivery. And a day before, and 2 days before, etc.
At some point, you can argue that the foetus is not alive, I suppose, but obivously the question is more complex than argument that just because the bun is still in the oven it cannot possibly be alive. So in many cases, abortion can literally mean ending a life, whereas in other, much earlier stages, it doesn't mean ending a life.
No. It goes to show how it's still the best for 'some' projects.
For other tasks, C# or Java or something else would be equally fast but many times easier to develop, easier to test and easier to maintain. It all depends on the context of the project. there is no single 'teh best' (typo intentional) programming language.