Regulatory Process Quotes

Consider the clinicaltrials by which drugs are tested in human subjects.5 Before a new drug can enter the market, its manufacturer must sponsor clinicaltrials to show the Food and Drug Administration that the drug is safe and effective, usually as compared with a placebo or dummy pill. The results of all the trials (there may be many) are submitted to the FDA, and if one or two trials are positive—that is, they show effectiveness without serious risk—the drug is usually approved, even if all the other trials are negative.

We need an attorney general that's going to be an advocate for the state of Missouri and is willing to intervene in the regulatory process and go to court to protect Missourians from over-regulation.

There are two things nobody should ever have to watch being made, sausage and laws.

As was noted in the Wall Street Journal, last March 21st, FDA approval of drug labelling, '...requires seven to ten years, and costs each applicant an average of $70 million.'

The SEC got more than 100 rules to write under Dodd-Frank, the lion's share of all the agencies. And we've moved, I think, with a tremendous sense of urgency. But it takes a long time to write rules and get them approved by a five-member commission.

The process of getting regulations right is described publicly as far more political than in fact it is. It's essentially a legal and technical enterprise.

While public participation in the promulgation of new regulations is allowed, and often required, the process is generally perfunctory and dismissive.

I cannot understand for the life of me why DOE is going forward with this licensing procedure when we do not know whether or not the scientific documentation upon which you are basing your decisions is, in fact, flawed.

I have been trying to understand the regulators.

If a State has reliable scientific information that demonstrates that a warning is needed for a particular food, then in the interest of public health, it should share that information with the FDA and petition for a new national standard.

Sausage making and policy-making shouldn't be seen close-up.

'Sue and settle' involves the creation of environmental rules and regulations through lawsuits filed by environmental groups against the EPA, not through Congress or proper rule-making.

Obviously, Nevada doesn't prohibit all forms of gambling, but you have to submit yourself to a very rigorous regulatory process to run a gambling operation in Nevada.

Great Britain revolutionized parts of their regulatory process by actually bringing the people who were going to be regulated to the table and suddenly found that they could solve the problems at a lot lower cost by, again, going back to the thing that tends to be most uninteresting, particularly in cable news, and looking at the actual process.

You don't build a new power plant in the United States overnight. It takes years to build.

If you're a realist, you know that people have different roles to play in politics, economics, and this is an important role, but I do think that there has to be an understanding of how what happens here on Wall Street has such broad consequences not just for the domestic but the global economy, so more thought has to be given to the process and transactions and regulations so that we don't kill or maim what works, but we concentrate on the most effective way of moving forward with the brainpower and the financial power that exists here.

We should look for ways to expedite generic drug approvals, particularly for products that have a long history of being safe and effective.

We are pleased with the very positive reception our offer has received, and are confident that progress is being made towards establishing the regulatory framework for the offer.

When decisions on nuclear power stations and runways are delayed and the government dilly-dallies, people think they aren't important.

Erasing the ALJ process, even if it takes legislation, will not deny anyone due individual process, generate added litigation risks or substantially increase workloads for commissioners or staff.